ATORVASTATIN HEC PHARM 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatin HEC Pharm 20 mg Film-Coated Tablets EFG

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, pharmacist, or nurse.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Atorvastatin HEC Pharm and what is it used for
2. What you need to know before you take Atorvastatin HEC Pharm
3. How to take Atorvastatin HEC Pharm
4. Possible side effects
5. Storage of Atorvastatin HEC Pharm
6. Contents of the pack and other information

1. What is Atorvastatin HEC Pharm and what is it used for

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating medicines.

Atorvastatin is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have not worked. If you are at high risk of heart disease, atorvastatin may also be used to reduce this risk even if your cholesterol levels are normal. You should maintain a standard cholesterol-lowering diet during treatment.

2. What you need to know before you take Atorvastatin HEC Pharm

Do not take Atorvastatin HEC Pharm:

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6).

• if you have or have had any liver disease.
• if you have had any unexplained abnormal blood test results showing liver function problems.
• if you are a woman able to have children and are not using reliable contraception.
• if you are pregnant or trying to become pregnant.

• if you are breast-feeding.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking atorvastatin:

• if you have severe respiratory problems.

• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and atorvastatin can cause muscle problems (rhabdomyolysis).
• if you have had a previous stroke with bleeding in the brain, or have small pockets of fluid in the brain due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have had repeated or unexplained muscle pains or have a family history of muscle problems.
• if you have previously had muscle problems while taking other lipid-lowering medicines (e.g. other statins or fibrates).
• if you regularly drink large amounts of alcohol.
• if you have a history of liver problems.
• if you are over 70 years old.

In any of these cases, your doctor may decide to carry out blood tests before and possibly during treatment with atorvastatin to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Using atorvastatin with other medicines").

Also, tell your doctor or pharmacist if you experience any unexplained muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

While you are on this medicine, your doctor will check you for signs of diabetes or an increased risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatin HEC Pharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that may affect the way atorvastatin works or the effects of these medicines may be changed by atorvastatin. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

• Medicines used to modify the functioning of your immune system, e.g. ciclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for regulating lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used to treat angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used in the treatment of AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.

• Other medicines that are known to interact with atorvastatin include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazon (a pain reliever), colchicine (used for treating gout), and antacids (indigestion products containing aluminum or magnesium).
• Medicines obtained without a prescription: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will tell you when it is safe to restart atorvastatin treatment. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatin HEC Pharm with food, drinks, and alcohol

For instructions on how to take atorvastatin, see section 3. Please note the following:

Grapefruit juice:

Do not take more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of atorvastatin.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

Do not take atorvastatin if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not take atorvastatin if you are of childbearing age unless you are using reliable contraception. Do not take atorvastatin if you are breast-feeding.

The safety of atorvastatin during pregnancy and breast-feeding has not been established.

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

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if this medicine affects your ability to use them.

Atorvastatin HEC Pharm contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Atorvastatin HEC Pharm contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially "sodium-free".

3. How to take Atorvastatin HEC Pharm

Before starting treatment, your doctor will put you on a cholesterol-lowering diet, which you should follow while taking atorvastatin.

The usual starting dose of atorvastatin is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase the dose if necessary, up to the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once a day.

Atorvastatin tablets should be swallowed whole with a glass of water and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin HEC Pharm

Ask your doctor if you think the effect of atorvastatin is too strong or too weak.

If you take more Atorvastatin HEC Pharm than you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20, stating the medicine and the amount taken. Take the remaining tablets, the box, and the complete package so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatin HEC Pharm

If you forget to take a dose, take the next scheduled dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin HEC Pharm

If you have any further questions on the use of this medicine or wish to stop treatment, 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 notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or go to the nearest hospital emergency department.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in breathing.

• Severe skin disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.

• Weakness, muscle tenderness, or brownish-red discoloration of the urine, and especially if you also have discomfort or high fever, which may be due to abnormal muscle destruction (rhabdomyolysis). The abnormal breakdown of muscles does not always go away, even after stopping atorvastatin, and can be fatal and cause kidney problems.

Very rare: may affect up to 1 in 10,000 people

• If you experience bleeding or bruising problems, this may suggest a liver problem. You should consult your doctor as soon as possible.

• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with atorvastatin

Common: may affect up to 1 in 10 people

• nose inflammation, sore throat, nosebleeds
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function

Uncommon: may affect up to 1 in 100 people

• loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, you should continue to monitor your blood sugar levels carefully)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• hepatitis (inflammation of the liver)
• skin rash, skin rash and itching, hives
• neck pain, muscle fatigue
• fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature
• positive urine tests for white blood cells

Rare: may affect up to 1 in 1,000 people

• vision changes
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and the whites of the eyes)
• tendon injury

Very rare: may affect up to 1 in 10,000 people

• allergic reaction - symptoms may include sudden wheezing, coughing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

Frequency not known: cannot be estimated from the available data: Persistent muscle weakness

Possible side effects of some statins (medicines of the same type):

• Sexual difficulties
• Depression
• Respiratory problems such as persistent cough and/or difficulty breathing or fever
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience 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 Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin HEC Pharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after {CAD}. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin HEC Pharm

The active substance is atorvastatin.

Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other ingredients (excipients) are:

lactose monohydrate, microcrystalline cellulose PH101, calcium carbonate, sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, and magnesium stearate.

The coating of Atorvastatin HEC Pharm contains:

hypromellose 2910, macrogol 8000, titanium dioxide (E-171), talc, yellow iron oxide (E-172), red iron oxide.

Appearance of the product and contents of the pack

Atorvastatin HEC Pharm 20 mg: yellow, oval, film-coated tablets, marked with "C35" on one side and smooth on the other. The tablet size is 12.15 * 6.3 mm.

Blister packs (OPA/AL/PVC) with a cold-sealed aluminum foil and another aluminum foil from which the tablets are extracted.

Blister packs (OPA/AL/PVC) in packs of 28, 30, 50, 90, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17,

10963 Berlin,

Germany

Manufacturer

Formula Pharmazeutische And Chemische Entnicklungs GmbH

Goerzalle 305 b

Lichterfelde, D-14167 Berlin

Germany

Date of last revision of this leaflet: July/2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/