Lymecyclin Orifarm 300 mg Kapsel, hård

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

10-07-2018

Produktens egenskaper Produktens egenskaper (SPC)

10-07-2018

Aktiva substanser:
lymecyklin
Tillgänglig från:
Orifarm AB
ATC-kod:
J01AA04
INN (International namn):
lymecycline
Dos:
300 mg
Läkemedelsform:
Kapsel, hård
Sammansättning:
lymecyklin 408 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
55044
Tillstånd datum:
2017-02-15

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

06-07-2018

Produktens egenskaper Produktens egenskaper - engelska

06-07-2018

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Package leaflet: Information for the user

Lymecycline Actavis 408 mg capsule, hard

Lymecycline

(equivalent to 300 mg of tetracycline base)

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4

What is in this leaflet

What /…/ is and what it is used for

What you need to know before you take /.../

How to take /.../

Possible side effects

How to store /.../

Contents of the pack and other information

1.

What /.../ is and what it is used for

/.../ belongs to a group of medicines called tetracycline antibiotics.

/.../ is used for the treatment of moderate to severe acne.

It prevents the growth of bacteria in infections such as:

Acne - appears as blackheads and whiteheads which people often refer to as pimples or spots. /.../

attacks the bacteria that are one of the main causes of acne. The name of these bacteria is

propionibacterium acnes

. If you are not sure why you have been prescribed this medicine, talk to your

doctor.

2.

What you need to know before you take /.../

Do not take /.../

if you are allergic to lymecycline, any other tetracyclines antibiotics or any of the other

ingredients of this medicine (listed in section 6)

if you have ever had kidney disease.

if you are pregnant, planning to become pregnant or are breastfeeding.

if you are taking systemic retinoids including oral retinoids (these include some other medicines

used to treat acne).

/…/ must not be given to children under 8 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking /…/

if you have had liver problems

if you have had kidney problems

if you suffer from systemic lupus erythematosus (an allergic condition that causes joint pain,

skin rashes or fever)

if you suffer from Myasthenia Gravis (a disease that weakens the muscles) .

You should avoid direct exposure to sunlight or artificial sunlight from sunbeds. If you experience

skin discomfort then stop taking this medicine and seek advice from your doctor.

Children and adolescents

/.../ is not recommended for use in children under 12 years of age as it can cause permanent

discolouration of tooth enamel and affect bone development.

Other medicines and /…/

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

Do not take the following medicines at the same time as /.../, as these could affect how well /…/

works. Take them at least two hours before /.../ or two hours after:

indigestion remedies

ulcer healing drugs

quinapril (for high blood pressure)

supplements containing calcium, aluminium, magnesium, zinc or iron.

didanosine (used to treat HIV)

Tell your doctor if you are taking any of the following:

systemic retinoids including oral retinoids (to treat acne).

anticoagulants (to stop the blood clotting)

diuretics (used to treat kidney disease, heart disease or high blood pressure)

/…/ with food and drink

Absorption of /.../ is not affected by moderate amounts of milk (e.g. a glass). /.../ should always be

taken with a glass of water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

/.../ must not be taken if you are pregnant or breast feeding.

Use of medicines such as /.../ may affect the proper growth of developing teeth and lead to permanent

discolouration.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed

3.

How to take /.../

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

Adults and children over 12 years

Moderate to severe acne

The normal dose is one /.../ capsule once a day, preferably in the morning. /.../ capsules should always

be taken with a glass of water, whilst in an upright position. They should also be taken with a light

meal without dairy products.

How long you will have to take /.../ for will depend on how quickly your condition improves. For

acne, this will normally be at least 8 to 12 weeks. Your physician may decide to continue with

treatment for a maximum of 6 months.

Children

Do not give /.../ to children below the age of 8.

/.../ is not recommended for use in children under 12 years of age as it can cause permanent

discolouration of tooth enamel and affect bone development.

Kidney impairment

If you have a kidney problem your doctor may decide to reduce your dose.

If you take more /.../ than you should

If you (or someone else) takes too many capsules, or you think a child may have swallowed any,

contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take /.../

If you forget to take a dose, simply take it when you remember and carry on as before unless it is time

for the next dose. Do not take a double dose to make up for a forgotten dose. You should never take

more capsules than your doctor recommends.

If you stop taking /.../

Acne responds slowly to antibiotics. It is important that you take all the /.../ that your doctor has

prescribed for you. If you stop taking /.../ too soon, your acne or infection could get worse or come

back.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking your capsules and tell your

doctor immediately or go to the nearest hospital accident and emergency department. This

includes any side effects not listed in this leaflet.

Not known frequency of occurrence

(frequency cannot be estimated from the available data):

Serious allergic reaction which causes swelling of the face, tongue and throat that can cause

great difficulty in breathing.

Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes,

genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet

which may blister.

/.../ may also cause the following side effects:

Common side effects

(may affect up to 1 in 10 people)

nausea (feeling sick)

abdominal pain

diarrhoea

headache

Not known frequency of occurrence

(frequency cannot be estimated from the available data)

disturbances of eyesight

dizziness

vomiting (being sick)

yellowing of the skin or eyes (jaundice)

increased sensitivity of the skin to sunlight

increased pressure in the brain

changes in the number or type of certain blood cells

pain in the upper part of the abdomen

changes in some blood tests (tests of liver function)

fever

itchiness, skin rash or hives

inflammation of the intestine

The following side effects may occur during treatment with the class of medicines to which /.../

belongs (the tetracyclines):

inflammation or ulceration of the gullet, causing pain or difficulty swallowing or painful

heartburn.

difficulty in swallowing

inflammation of the pancreas

liver damage

teeth discolouration

inflammation or soreness of the tongue, mouth, cheeks, gums or lips

soreness or itching of the genital area

yeast infection around the anus or genitals

infection of the colon

permanent visual loss

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store /…/

Keep this medicine out of the sight and reachof children.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The

expiry date refers to the last day of that month.

Store below 25°C

Store in the original package in order to protect from light

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What /.../ contains

The active substance is lymecycline. Each capsule contains 408 mg of lymecycline equivalent to

300 mg tetracycline

The other ingredients are colloidal hydrated silica, magnesium stearate, capsule body: titanium

dioxide (E171), gelatine, capsule cap: indigo carmine (E132), black iron oxide (E172), titanium

dioxide (E171), yellow iron oxide (E172), gelatine.

What /.../ looks like and contents of the pack

Hard gelatin capsule size 0, blue cap and white body

16, 20, 21, 28, 56 and 100 capsules in Al/Al blister.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

<This medicinal product is authorised in the Member States of the EEA under the following

names:>

<{Name of the Member State}> <{Name of the medicinal product}>

<{Name of the Member State}> <{Name of the medicinal product}>

This leaflet was last revised in

2018-07-06

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Lymecycline Actavis 408 mg capsule, hard

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 408 mg of lymecycline equivalent to 300 mg tetracycline

For the full list of excipients, see section 6.1

3.

PHARMACEUTICAL FORM

Capsule, hard

Hard gelatin capsule size 0, blue cap and white body

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Lymecycline is indicated for the treatment of moderate to severe acne vulgaris (see sections 4.4 and

5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents

4.2

Posology and method of administration

Posology

Adults

The usual dosage for the long-term treatment of moderate to severe acne is 1 capsule daily. Treatment

should be continued for at least 8 weeks to 12 weeks, however it is important to limit the use of

antibiotics to the shortest possible period and discontinue their use when further improvement is

unlikely. The treatment should not exceed a duration of 6 months.

Elderly

As for other tetracyclines, no specific dose adjustment is required.

Paediatric population

The safety and efficacy of /…/ in children aged under 12 years of age have not been established. No

data are available.

For children over the age of 12 years, the adult dosage may be given.

For children under the age of 8 years, see section 4.3.

Renal impairment

The excretion rate for tetracycline is reduced in case of renal insufficiency and thus normal dosage

may lead to accumulation. In case of renal insufficiency it is recommended to lower the dose and

possibly to control serum levels.

Method of administration

The capsules must be taken with at least half a glass of water whilst in an upright position. It should be

taken with a light meal without dairy products.

4.3

Contraindications

/.../ is contraindicated in:

hypersensitivity to the active substance, any other tetracycline or to any of the excipients listed

in section 6.1.

patients with severe renal impairment

children aged under 8 years due to the risk of permanent dental staining and enamel hypoplasia.

pregnancy and during breast feeding.

concurrent treatment with oral retinoids and use in association with systemic retinoids (see

sections 4.5 and 4.8).

4.4

Special warnings and precautions for use

Prolonged use of broad spectrum antibiotics may result in the appearance of resistant organisms and

superinfections.

Cross-resistance between tetracyclines may develop in micro-organisms, and cross sensitisation in

patients.

Tetracyclines should only be used with caution in patients with hepatic dysfunction, lest accumulation

occurs with increased toxicity. Careful monitoring of dosage by serum levels is necessary. High

dosage of tetracyclines may be hepatotoxic and great care should be used with concurrent

administration of other hepatotoxic drugs.

Tetracyclines may cause photosensitivity reactions, manifested by an exaggerated sunburn; however,

very rare cases have been reported with lymecycline. Patients should be informed that this reaction

may occur and be warned to avoid direct exposure to natural and artificial sunlight and that treatment

should be discontinued at the first evidence of skin erythema or skin discomfort.

May cause exacerbation of systemic lupus erythematosus.

Can cause weak neuromuscular blockade so should be used with caution in Myasthenia Gravis.

Tetracyclines are absorbed to some extent by developing bones and teeth and may produce staining

and enamel hypoplasia.

Tetracyclines should only be administered with great caution in patients with renal insufficiency lest

accumulation occurs with increased toxicity. Dosage may require reduction. High dosage of

tetracyclines may be nephrotoxic.

Bulging fontanelles in infants and benign intracranial hypertension in adults has been reported during

treatment with tetracyclines. Therefore treatment should cease if evidence of raised intracranial

pressure develops during treatment with lymecycline.

Regarding moderate acne vulgaris, lymecycline is indicated only if topical treatment is not effective.

4.5

Interaction with other medicinal products and other forms of interaction

The absorption of tetracyclines may be affected by the simultaneous administration of calcium,

aluminium, didanosine, magnesium, bismuth and zinc salts, antacids, Bismuth containing ulcer-

healing drugs, iron preparations and quinapril.

The following combinations should therefore be avoided:

Antacids: Antacids containing di- or tri-valent cations form chelate complexes with tetracyclines,

resulting in reduced absorption.

Sodium bicarbonate has been reported to inhibit the absorption of tetracyclines due to change in pH.

Quinapril: Quinapril tablets contain magnesium which forms chelate complexes with tetracycline

resulting in reduced absorption.

Didanosine: Didanosine in tablet form contains trivalent cations which form chelate complexes with

tetracycline resulting in reduced absorption. There are however no experimental studies.

Combinations where dose adjustment is recommended:

Zinc, calcium, iron: In concomitant treatment, the absorption of tetracyclines is reduced.

These products should not be taken within two to three hours before or after taking lymecycline

capsules.

Concomitant use of systemic retinoids including oral retinoids should be avoided as this may increase

the risk of benign intracranial hypertension. An increase in the effects of anticoagulants may occur

with tetracyclines. Concomitant use of diuretics should be avoided because of their association with

rises in blood urea nitrogen levels.

Lymecycline could cause false-positive urine glucose determinations. It could also interfere with

fluorometric determinations of urine catecholamines resulting in falsely increased values (Hingerty's

method).

4.6

Fertility, pregnancy and lactation

Pregnancy

The effect of tetracycline on embryofoetal development in animals has not been reported.

Tetracyclines readily cross the placenta barrier.

Tetracyclines are selectively absorbed by developing bones and teeth and may cause dental staining

and enamel hypoplasia. Therefore, lymecycline should not be administered to pregnant women (see

section 4.3).

Breastfeeding

Tetracyclines are distributed into milk.Therefore, lymecycline should not be administered to breast-

feeding women (risk of enamel hypoplasia or dental dyschromia in the infant) (see section 4.3).

Fertility

In humans, the effect of lymecycline on fertility is unknown. In the rat, tetracyclines caused a

reduction in the weight of the testis, epididymis and seminal vesicle. In addition a reduction in sperm

motility, percentage live spermatozoa and changes in testicular histopathology were noted.

4.7

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed

4.8

Undesirable effects

The most frequently reported adverse events with lymecycline are gastrointestinal disorders of nausea,

abdominal pain, diarrhoea and nervous system disorder of headache.

The most serious adverse events reported with lymecycline are Stevens Johnson syndrome,

anaphylactic reaction, angioneurotic oedema and intracranial hypertension.

The following definitions of frequencies are used:

Common

(≥1/100 to <1/10)

Not known

(cannot be estimated from the available data)

System Organ Class

Frequency

Adverse Reaction

Blood and lymphatic system disorders

Not known

Neutropenia

Thrombocytopenia

Immune system disorders

Not known

Anaphylactic reaction

Hypersensitivity

Urticaria

Angioneurotic oedema

Common

Headache

Nervous system disorders

Not known

Dizziness

*Intracranial hypertension

Eye disorders

Not known

Visual disturbance

Common

Nausea

Abdominal pain

Diarrhoea

Gastrointestinal disorders

Not known

Epigastralgia

Glossitis

Vomiting

Enterocolitis

Hepatobiliary disorders

Not known

Jaundice

Skin and subcutaneous tissues disorders

Not known

Erythematous rash

Photosensitivity

Pruritus

Stevens Johnson syndrome

General disorders and administration site

conditions

Not known

Pyrexia

Investigations

Not known

Transaminases increased

Blood alkaline phosphatase

increased

Blood bilirubin increased

*(N.B. the occurrence of clinical symptoms including visual disturbance or headache should raise the

possibility of the diagnosis of cranial hypertension. The treatment should be interrupted if raised intra-

cranial pressure is suspected during lymecycline treatment.

General tetracyclines adverse events:

Benign intracranial hypertension and bulging fontanelles in infants were reported with tetracyclines

with possible symptoms of headaches, visual disturbances including blurring of vision, scotomata,

diplopia or permanent visual loss.

The following adverse effects were reported with tetracyclines in general and may occur with

lymecycline:

dysphagia, oesophagitis, oesophageal, ulceration, pancreatitis, teeth discolouration, hepatitis, hepatic

failure.

Dental dyschromia and/or enamel hypoplasia may occur if the product is administered in children

younger than 8 years of age.

As with all antibiotics overgrowth of non susceptible organisms may cause candidiasis,

pseudomembranous colitis (Clostridium Difficile overgrowth), glossitis, stomatitis, vaginitis or

staphyloccocal enterocolitis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the national reporting system

listed in Appendix V.

4.9

Overdose

There is no specific treatment, but gastric lavage should be performed as soon as possible. Supportive

measure should be instituted as required and a high fluid intake maintained.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Tetracyclines, ATC code: J01AA04

Mode of action

Tetracyclines provide bacteriostatic action at the available plasma and tissue concentrations and are

effective against intracellular and extracellular organisms. Their mechanism of action is based on an

inhibition of ribosomal protein synthesis. Tetracyclines block the access of the bacterial aminoacyl-

tRNA to the mRNA-ribosome complex by binding to the 30S subunit of the ribosome, thus preventing

the addition of amino acids to the growing peptide chain in protein synthesis. When given at

therapeutically attainable concentrations their toxic effect is limited to the bacterial cells. The exact

mechanisms by which tetracyclines reduce lesions of acne vulgaris have not been fully elucidated;

however, the effect appears to result in part from the antibacterial activity of the drugs. Following oral

administration, the drugs inhibit the growth of susceptible organisms (mainly Propionibacterium

acnes) on the surface of the skin and reduce the concentration of free fatty acids in sebum. The

reduction in free fatty acids in sebum may be an indirect result of the inhibition of lipase-producing

organisms which convert triglycerides into free fatty acids or may be a direct result of interference

with lipase production in these organisms. Free fatty acids are comedogenic and are believed to be a

possible cause of the inflammatory lesions, e.g. papules, pustules, nodules, cysts, of acne. However,

other mechanisms also appear to be involved because clinical improvement of acne vulgaris with oral

tetracycline therapy does not necessarily correspond with a reduction in the bacterial flora of the skin

or a decrease in the free fatty acid content of sebum.

Mechanism of resistance

Tetracycline resistance in propionibacteria is usually associated with a single point mutation within the

gene encoding 16S rRNA. Clinical isolates resistant to tetracycline were found to have cytosine

instead of guanine at a position cognate with

Escherichia coli

base 1058. There is no evidence that

ribosome mutations can be transferred between different strains or species of propionibacteria, or

between propionibacteria and other skin commensals.

Resistance to the tetracyclines is associated with mobile resistance determinants in both staphylococci

and coryneform bacteria. These determinants are potentially transmissible between different species

and even different genera of bacteria.

In all three genera, cross-resistance with the macrolide-lincosamide-streptogramin group of antibiotics

cannot be ruled out.

Strains of propionibacteria resistant to the hydrophilic tetracyclines are cross-resistant to doxycycline

and may or may not show reduced susceptibility to minocycline.

Breakpoints

No breakpoints are listed for

Propionibacterium acnes

in the current EUCAST tables.

Susceptibility to tetracyclines of species relevant to the approved indication

Commonly susceptible species

Gram-positive Anaerobes

Propionibacterium acnes

(clinical isolates)*

*Even if resistance to cutaneous propionibacteria is detected, this does not automatically translate

into therapeutic failure, since the anti-inflammatory activity of the tetracyclines is not compromised by

resistance in the target bacteria.

5.2

Pharmacokinetic properties

During absorption lymecycline is quickly hydrolysed to active tetracycline and other, inactive,

constituents. Free tetracycline, which is quickly absorbed, gives therapeutic serum concentrations

(>1 microgram/ml) for at least 12 hours. Therapeutic serum concentrations are reached within one

hour and maximum serum concentrations (2-3 microgram/ml) are reached within 2-3 hours. Doubling

the dose gives 80% increase in serum concentrations.

The serum half-life of lymecycline is approximately 10 hours.

5.3

Preclinical safety data

There are no non-clinical data of relevance to the prescriber which are additional to that already

included in other sections of this SmPC.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Silica colloidal, hydrated

Magnesium stearate

Capsule Body:

Titanium dioxide (E171)

Gelatine

Capsule Cap:

Indigo carmine (E132)

Black iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatine

6.2

Incompatibilities

Not applicable

6.3

Shelf life

15 months

6.4

Special precautions for storage

Store below 25

Store in the original package in order to protect from light

6.5

Nature and contents of container

Al/Al blister

Blister: 16, 20, 21, 28, 56 and 100 capsules.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

<[To be completed nationally]>

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

8.

MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

<DD/MM/YYYY}> <{DD month YYYY}>

<[To be completed nationally]>

10.

DATE OF REVISION OF THE TEXT

2018-07-06

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