ATORVASTATIN TEVA 80 MG

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed

with a doctor’s prescription only

Atorvastatin

Teva

®

10 mg

Tablets

The active ingredient and its quantity:

Each tablet contains:

Atorvastatin 10 mg (as calcium)

Atorvastatin

Teva

®

20 mg

Tablets

The active ingredient and its quantity:

Each tablet contains:

Atorvastatin 20 mg (as calcium)

Atorvastatin

Teva

®

40 mg

Tablets

The active ingredient and its quantity:

Each tablet contains:

Atorvastatin 40 mg (as calcium)

Atorvastatin

Teva

®

80 mg

Tablets

The active ingredient and its quantity:

Each tablet contains:

Atorvastatin 80 mg (as calcium)

For the list of inactive ingredients, please see

section 6.

Read this leaflet carefully in its entirety before

using the medicine. This leaflet contains concise

information about the medicine. If you have further

questions, refer to the doctor or pharmacist.

This medicine has been prescribed for your

treatment. Do not pass it on to others. It may

harm them even if it seems to you that their

medical condition is similar to yours.

This medicine is not usually intended for

children under the age of 10.

Be sure to maintain a low-cholesterol diet and

to perform physical activity in addition to use

of this medicine.

1. WHAT IS THE MEDICINE INTENDED

FOR?

∙ The medicine is intended to reduce blood lipid

levels (cholesterol and triglycerides) and to

increase HDL.

∙ To prevent heart and vascular diseases (such

as heart attack and stroke) in patients at high

risk for a primary event.

∙ In patients with coronary heart disease, the

medicine reduces the risk of myocardial

infarction, stroke, hospitalization due to

heart failure, angina pectoris and/or need for

catheterization.

Therapeutic group:

Statins

HMG-CoA

reductase

enzyme

inhibitors.

2. BEFORE USING THE MEDICINE:

Do not use the medicine if:

∙ you are pregnant, intend to become

pregnant, are breastfeeding or intend to

breastfeed.

∙ you are a woman of child-bearing age and

are not using appropriate contraceptive

methods.

∙ you are sensitive to atorvastatin, similar

medicines used to lower blood lipid

levels or to the inactive ingredients of the

preparation.

∙ Do not use this medicine in case of an active

liver disease or if you have a persistent

elevation of blood transaminase (liver

enzymes) levels.

∙ you are suffering from a disease of the

skeletal muscles.

∙ Do not use the medicine in children below

10 years of age and in girls who have not

yet started menstruating.

∙ you are taking cyclosporine, telaprevir

(for the treatment of hepatitis C), or a

combination of tipranavir and ritonavir (for

the treatment of the AIDS virus).

Special warnings regarding use of the

medicine:

∙ The preparation contains sodium and lactose

and may cause allergy in people sensitive to

either of these substances.

∙ During the course of treatment with this

medicine, it is recommended to visit a doctor

regularly.

∙ Refer to a doctor immediately if you think you

are pregnant.

∙ Before surgery (including dental surgery) or an

emergency procedure, inform the doctor that

you are taking this medicine.

∙ Women of child-bearing age must use

appropriate contraceptive methods.

∙ Refer to a doctor immediately if muscle pain,

tenderness or weakness occur, especially if

these effects are accompanied by unusual

fatigue or fever.

∙ Concomitant administration of atorvastatin

with fibric acid derivatives, erythromycin,

clarithromycin, protease inhibitors to treat

AIDS, niacin, ezetimibe, fusidic acid, azole

antifungals or colchicine may increase the

risk of muscle damage (see section 4 – "Side

Effects" in the leaflet). Regarding fusidic

acid, the doctor must consider temporary

discontinuation of treatment with Atorvastatin

Teva.

∙ Statins may increase the risk of onset of

diabetes in patients who are in a risk group;

blood sugar levels must be monitored in

these patients. If you are at increased risk of

developing diabetes (borderline blood sugar

levels, significant overweight, high blood lipid

levels or high blood pressure), monitoring by a

doctor and periodic blood tests are necessary

during the course of treatment with the

medicine.

∙ Do not drink more than one or two small cups

of grapefruit juice per day, as consumption of

large quantities of grapefruit may affect the

activity of the medicine.

If you are sensitive to any food or medicine,

inform the doctor before taking the medicine.

Before treatment with Atorvastatin Teva,

tell the doctor if:

∙ if you are over the age of 70.

∙ if you are suffering, or have suffered in the past,

from impaired function of the liver, kidney/

urinary system, thyroid, serious problems in

the respiratory system.

∙ if you consume a lot of alcohol or if you used to

drink large quantities of alcohol in the past.

∙ if you recently experienced a stroke or

a transient ischemic attack or you are

suffering, or have suffered, from cerebral

hemorrhaging.

∙ if you have suffered from recurrent or

unexplained muscle aches, or if you or your

family members are suffering from a muscle

disorder or if you suffered from muscle

problems during the course of treatment

with other medicines used for lowering blood

lipids.

∙ if you are suffering from seizures, a disorder

or deficiency in electrolytes or metabolic

enzymes, a severe infection, hypotension,

diabetes or if you recently underwent surgery

or trauma.

Tests that should be performed before using

the medicine:

∙ Before starting treatment with this medicine,

a liver function test should be performed.

If you are taking, or have recently taken,

other medicines, including non-prescription

medicines and nutritional supplements, tell

the doctor or pharmacist. In particular, inform

the doctor or pharmacist if you are taking:

∙ Medicines that in combination with atorvastatin

increase its blood concentration and may

increase the risk of muscle pain:

antibiotics

such

erythromycin,

clarithromycin, fusidic acid, other cholesterol-

lowering preparations (e.g., fibric acid

derivatives, nicotinic acid), antifungal

preparations from the azole group (e.g.,

ketoconazole, itraconazole), boceprevir (for

treatment of hepatitis C), colchicine (for

gout), medicines for the AIDS virus (protease

inhibitors) such as: saquinavir, ritonavir,

darunavir, fosamprenavir, lopinavir and

nelfinavir, indinavir.

∙ Medicines that in combination with atorvastatin

increase its blood concentration:

diltiazem (for the heart and blood vessels),

rifampicin (antibiotic) (concomitantly taken

with atorvastatin), amlodipine (to treat

hypertension).

∙ Medicines that in combination with atorvastatin

decrease its blood concentration:

efavirenz (e.g., Stocrin), rifampicin (antibiotic)

(not administered in proximity to atorvastatin),

antacids (containing magnesium or aluminum).

∙ Medicines whose blood concentrations rise

when given in combination with atorvastatin:

oral contraceptives containing norethindrone

and ethinylestradiol, digoxin (for the heart) -

you should be monitored.

If you are taking anticoagulants (warfarin) -

coagulation parameters should be monitored.

∙ Do not take Atorvastatin Teva together with the

following medicines: cyclosporine, telaprevir

(for treatment of hepatitis C), or a combination

of tipranavir and ritonavir (for treatment of the

AIDS virus).

Additional interactions with Atorvastatin

Teva:

∙ Medicines that affect the heart rate (e.g.,

amiodarone)

Other preparations for regulation of blood lipid

levels (e.g., colestipol, ezetimibe, gemfibrozil)

∙ Calcium channel blockers used to treat

hypertension and angina pectoris (e.g.,

verapamil)

∙ St. John’s wort (Hypericum perforatum),

nefazodone (antidepressant)

∙ Medicines for epilepsy (e.g., phenytoin)

∙ Cimetidine (to inhibit secretion of gastric

acids)

∙ Phenazone, corticosteroids.

Use of the medicine and food:

Swallow the tablet whole with a little water.

The medicine can be taken with or without

food.

Be sure to maintain a low-cholesterol diet during

the course of treatment with this medicine.

Do not drink more than one or two small cups of

grapefruit juice per day, as consumption of large

quantities of grapefruit may affect the activity of

the medicine.

Use

of

the

medicine

and

alcohol

consumption:

Do not drink a lot of alcohol - do not drink large

quantities of wine or alcoholic beverages during

the course of treatment with the medicine (see

section 2 - subsection “Before treatment with

Atorvastatin Teva, tell the doctor if”).

Pregnancy and breastfeeding:

Do not use this medicine if you are pregnant,

intend to become pregnant, are breastfeeding

or intend to breastfeed.

Do not use this medicine if you are of child-

bearing age unless you use appropriate

contraceptive methods.

Refer to a doctor immediately if you think you

are pregnant.

Important information regarding some of

the ingredients of the medicine:

∙ Regarding Atorvastatin Teva 10 mg:

Each tablet contains 60.84 mg lactose.

∙ Regarding Atorvastatin Teva 20 mg:

Each tablet contains 121.68 mg lactose.

∙ Regarding Atorvastatin Teva 40 mg:

Each tablet contains 243.36 mg lactose.

∙ Regarding Atorvastatin Teva 80 mg:

Each tablet contains 486.74 mg lactose.

3. HOW

SHOULD

YOU

USE

THE

MEDICINE?

∙ Always use according to the doctor’s

instructions. Check with the doctor or

pharmacist if you are uncertain.

∙ Do not chew! Swallow the tablet whole with a

little water.

∙ Do not crush/halve/chew the tablet since it is

coated.

∙ Wait at least two hours between taking this

medicine and taking antacids.

∙ Attention - the bottle contains an oxygen

absorber and a desiccant (plastic rolls). Do

not swallow! Leave the oxygen absorber and

desiccant in the bottle and close the bottle

tightly after each use.

The dosage and treatment regimen will be

determined by the doctor only.

Use this medicine at specified time intervals, as

determined by the attending doctor.

Complete and adhere to the treatment as

recommended by the doctor.

Before starting treatment, the doctor will

instruct you about a low-cholesterol diet, which

you should maintain also during the course of

treatment with the medicine.

Tests and follow-up

∙ Before starting treatment with the medicine,

the doctor will refer you for a liver function

test.

During the course of treatment with this

medicine, the following tests should be

performed: liver function and blood lipid levels.

∙ If you have diabetes, continue to closely

monitor blood sugar levels. If you are at

increased risk of developing diabetes

(borderline blood sugar levels, significant

overweight, high blood lipid levels or high

blood pressure), monitoring by a doctor and

periodic blood tests are necessary during the

course of treatment with this medicine.

If you accidentally took a higher dosage

If you took an overdose or if a child accidentally

swallowed the medicine, immediately refer to a

doctor or proceed to a hospital emergency room

and bring the package of the medicine with you.

Do not induce vomiting without explicit instruction

from a doctor!

If you forgot to take this medicine at the

scheduled time, take a dose as soon as you

remember, but never take a double dose.

If you stop taking the medicine

If you want to stop using the medicine, consult

a doctor or pharmacist.

Even if there is an improvement in your health,

do not stop treatment with the medicine without

consulting the doctor. Reduction of the dosage

is usually done gradually.

∙ Do not take medicines in the dark! Check

the label and the dose each time you take a

medicine. Wear glasses if you need them.

∙ This medicine and any other medicine must be

kept in a safe place, out of the reach of children

and/or infants in order to avoid poisoning.

If you have further questions regarding use of

the medicine, consult a doctor or pharmacist.

4. SIDE EFFECTS:

As with any medicine, use of Atorvastatin Teva

may cause side effects in some users. Do not

be alarmed when reading the list of side effects.

You may not suffer from any of them.

Discontinue use of the medicine and refer to

a doctor immediately if:

You develop a severe allergic reaction which

causes swelling of the face, tongue and throat and

you suffer from breathing difficulties (rare). You

develop a severe skin reaction, which includes

peeling and swelling of the skin, blisters on the

skin, mouth, eyes, or genitals and fever (rare).

You develop a rash with pink-red spots on the

palms of the hands and soles of the feet (rare).

You develop muscle weakness, muscle

tenderness or pain, and if you simultaneously

feel bad and have a high fever. This may result

from muscle tissue breakdown which can be life-

threatening and lead to kidney problems (rare).

You suffer from sudden bleeding or bruises – this

may indicate liver problems. Refer to the doctor

immediately for advice (very rare).

Additional side effects:

Common side effects – inflammation of the

nasal passages, sore throat, nose bleed, allergic

reaction, increased blood sugar levels (if you

have diabetes, continue to closely monitor blood

sugar levels), increase in blood creatine kinase,

headache, nausea, constipation, flatulence,

indigestion, diarrhea, joint and muscle pains,

back pains, blood test results that indicate

impaired liver function.

Uncommon side effects – loss of appetite,

weight gain, decreased blood sugar levels (if you

have diabetes, continue to closely monitor blood

sugar levels), nightmares, insomnia, dizziness,

numbness or tingling in the fingers and toes,

decreased sensation of pain or touch, altered

sense of taste, memory loss (forgetfulness),

blurred vision, ringing in the ears/head,

vomiting, hiccups, abdominal pain, pancreatitis

(which may cause severe abdominal pain), liver

inflammation, rash, itching, urticaria, hair loss,

neck pain, muscle fatigue, fatigue, feeling unwell,

weakness, chest pain, swelling of the ankles

(edema), fever, white blood cells in the urine.

Rare side effects - visual disturbances,

unexpected bleeding and bruising, yellowing of

the skin and whites of the eyes, tendon injury.

Very rare side effects – hearing loss, enlargement

of the breasts in women and men.

Side effects reported with use of other statins -

sexual function difficulties, depression - refer to

a doctor!, shortness of breath, persistent cough,

fever, interstitial pulmonary disease that can be

manifested by shortness of breath, dry cough

and worsening of general health status (e.g.,

fatigue, weight loss and fever) - refer to a doctor

immediately!, diabetes, cognitive disturbances

(e.g., memory loss, confusion, forgetfulness) -

usually, these effects were not severe and

disappeared after discontinuing use of the

medicine - refer to a doctor!

If a side effect occurs, if any of the side effects

worsen or if you are suffering from a side

effect not mentioned in this leaflet, consult

the doctor.

Reporting side effects:

Side effects can be reported to the Ministry

of Health by clicking on the link “Report Side

Effects of Drug Treatment” found on the Ministry

of Health homepage (www.health.gov.il) that

directs you to the online form for reporting side

effects, or by entering the link:

https://forms.gov.il/globaldata/getsequence/get

sequence.aspx?formType=AdversEffectMedic@

moh.gov.il

5. HOW

SHOULD

THE

MEDICINE

BE

STORED?

∙ Avoid poisoning! This medicine and any other

medicine must be kept in a safe place out of

the reach and sight of children and/or infants

in order to avoid poisoning. Do not induce

vomiting without explicit instruction from the

doctor.

∙ Do not use the medicine after the expiry date

(exp. date) that appears on the package. The

expiry date refers to the last day of that month.

In any case of doubt, consult the pharmacist

who dispensed the medicine to you.

∙ Store below 25ºC. Store in the original

package.

∙ Do not store different medicines in the same

package.

∙ Bottle package: The preparation can be used

for up to 30 days after first opening the bottle,

but not beyond the expiry date.

6. FURTHER INFORMATION

∙ In addition to the active ingredient, the

medicine also contains (all 4 strengths):

Lactose

monohydrate,

crospovidone,

magnesium stearate, magnesium carbonate,

colloidal anhydrous silica, polydextrose,

titanium dioxide, hypromellose, macrogol/

PEG 4000.

∙ What the medicine looks like and the

contents of the package:

Atorvastatin Teva 10 mg:

White to off-white capsule-shaped tablet,

debossed with “93” on one side and “7310”

on the other side.

Atorvastatin Teva 20 mg:

White to off-white capsule-shaped tablet,

debossed with “93” on one side and “7311”

on the other side.

Atorvastatin Teva 40 mg:

White to off-white capsule-shaped tablet,

debossed with “93” on one side and “7312”

on the other side.

Atorvastatin Teva 80 mg:

White to off-white capsule-shaped tablet,

debossed with “93” on one side and “7313”

on the other side.

The package for each Atorvastatin Teva

strength contains 30 tablets.

The bottle package contains a desiccating

device and an oxygen absorbing device - do

not swallow them. They should be left in the

container.

∙ Registration holder and address: Teva

Pharmaceutical Industries Ltd., P.O.B. 3190,

Petach Tikva.

∙ Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

10 mg: 143.33.31993

20 mg: 143.34.31994

40 mg: 143.35.31995

80 mg: 143.36.31996

∙ This leaflet was checked and approved by the

Ministry of Health on 21.01.16.