Doxylar 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Doxycycline hyclate

Available from:

Sandoz Ltd

ATC code:

J01AA02

INN (International Name):

Doxycycline hyclate

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010300

Patient Information leaflet

Sandoz Ltd
Patient Information Leaflet
PL 04416/0007
Doxylar Capsules 100 mg
20/08/2018
PIL.0007.006.0d
V007 : Variation to update the SmPC and
leaflet to include paediatric information in
the SmPC of DOXYCYCLINE products
SL
LABEL-LEAFLET
DOXYLAR® CAPSULES 100MG
DOXYCYCLINE HYDROCHLORIDE
50 CAPSULES
Oral use.
Use as directed by your doctor.
Read the package leaflet before use.
Store in a cool, dry place. Protect from light. Keep out of the reach
and sight of children.
Each capsule contains doxycycline hydrochloride equivalent to
doxycycline BP 100 mg.
Also contains lactose, E171, E172 and E132.
PL 04416/0007
Sandoz Ltd, Woolmer Way, Bordon, Hants, GU35 9QE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• 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. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Doxylar Capsules are and what they are used for
2. Before you take Doxylar Capsules
3. How to take Doxylar Capsules
4. Possible side effects
5. How to store Doxylar Capsules
6. Further information
1 WHAT DOXYLAR CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Doxylar Capsules 100mg. The active
substance doxycycline
hydrochloride belongs to a group of medicines known as antibiotics or
anti-bacterial agents.
Doxylar may be used to treat a wide range of infections caused by
bacteria, these include:
• Respiratory tract infections such as sinusitis, pneumonia or
bronchitis.
• Infections of the urinary tract.
• Sexually transmitted diseases.
• Eye infections.
• Tick fevers, including Rocky Mountain spotted fever.
Sandoz Ltd
Patient Information Leaflet
PL 04416/0007
Doxylar Capsules 100 mg
20/08/2018
PIL.0007.006.0d
V007 : Variation to up

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Doxylar* Capsules 100mg
Ramysis Capsules 100mg
Doxycycline Capsules BP 100mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100mg capsule contains doxycycline hydrochloride equivalent to
doxycycline BP 100mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT
Doxycycline is clinically useful in the treatment of a variety of
infections caused
by susceptible strains of Gram-positive and Gram-negative bacteria and
certain
other micro-organisms. These include:
Respiratory tract infections: lower respiratory tract infections
including
pneumonia, due to susceptible strains of _Haemophilus influenzae,
Klebsiella _
_pneumoniae, Streptococcus pneumoniae_ and other organisms.
_Mycoplasma _
_pneumoniae_ pneumonia. The treatment of chronic bronchitis and
sinusitis.
Urinary infections: infections caused by susceptible strains of
Klebsiella,
Enterobacter, _Escherichia coli, Streptococcus faecalis_ and other
organisms.
Sexually transmitted diseases: infections including uncomplicated
urethral,
endocervical or rectal infections due to _Chlamydia trachomatis,_
non-gonoccal
urethritis, caused by _Ureaplasma urelyticulum_ (T-mycoplasma).
Doxycycline
can also be used to treat chancroid and infections due to
_Calymmatobacterium _
_granulomatis_ or as an alternative drug for the treatment of
gonorrhoea and
syphilis.
As a member of the tetracycline group of antibiotics, doxycycline may
be useful
in the treatment of infections due to other tetracycline-sensitive
micro-organisms
such as:
Ophthalmic infections: Due to _Haemophilus influenzae_ and susceptible
strains of
gonococci and staphylococci. Doxycycline is indicated in the treatment
of
trachoma. Inclusion conjunctivitis may be treated with oral
doxycycline alone,
or in combination with topical medication.
Rickettsial infections: tick fevers, Q fever, Rocky Mountain spotted
fever,
Coxiella endocarditis and typhus group.
Miscella