ATORVASTATIN 80 MG FILM-COATED TABLETS - Patient leaflet, side effects, dosage

1. what atorvastatin is and what it is used for

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

Atorvastatin is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatincan also be used to reduce such 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

Do not take Atorvastatin

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

• – if you have or have ever had a disease which affects the liver

• – if you have had any unexplained abnormal blood tests for liver function

• – if you are a woman able to have children and not using reliable contraception

• – if you are pregnant or trying to become pregnant

• – if you are breast-feeding.

• – If you use the combination of glecaprevir/pi­brentasvir in the treatment of hepatitis C

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Atorvastatin:

• – if you have severe respiratory failure

• – if you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Atorvastatin can lead to serious muscle problems (rhabdomyolysis).

• – if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes

• – if you have kidney problems

• – if you have an under-active thyroid gland (hypothyroidism)

• – if you have had repeated or unexplained muscle aches or pains, a personal history or family history of muscle problems

• – if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines)

• – if you regularly drink a large amount of alcohol

• – if you have a history of liver disease

• – if you are older than 70 years.

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Atorvastatin treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g rhabdomyolysis is known to increase when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatin”).

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure

Other medicines and Atorvastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may change the effect of Atorvastatin or their effect may be changed by Atorvastatin. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in section 4:

• Medicines used to alter the way your immune system works, e.g. ciclosporin
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, | itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid
• Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
• Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem,; 1 medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine that helps stop you from getting ill from cytomegalovirus.
• Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the i combination of tipranavir/ri­tonavir etc.
• Some medicines used in the treatment of hepatitis C e.g. telaprevir, boceprevir and the combination of elbasvir/grazo­previr, ledipasvir/so­fosbuvir.
• Other medicines known to interact with Atorvastatin include ezetimibe (which lowers cholesterol), warfarin | (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout) and antacids (indigestion products containing aluminium 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 need to temporarily stop using this | medicine. Your doctor will tell you when it is safe to restart Atorvastatin. Taking Atorvastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4

Atorvastatin with food and drink

See section 3 for instructions on how to take Atorvastatin. Please note the following: Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atorvastatin.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and precautions” for details

Pregnancy and breast-feeding

Do not take Atorvastatin if you are pregnant, or if you are trying to become pregnant.

Do not take Atorvastatin if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take Atorvastatin if you are breast-feeding.

The safety of Atorvastatin during pregnancy and breast-feeding has not yet been proven. 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 operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Atorvastatin contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact you doctor before taking this medicinal product.

Atorvastatin contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”

3. how to take atorvastatin

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atorvastatin.

The usual starting dose of Atorvastatin is 10 mg once a day in adults and children aged 10

years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt 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 drink 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 or symptoms, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

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

• – 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.

• – Muscle weakness, tenderness, pain, rupture or red-brown discolouration of urine and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown (rhabdomyolysis). The abnormal muscle breakdown does not always go away, even after you have stopped taking Atorvastatin , and it can be life-threatening and lead to kidney problems.

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

• – If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

• – Lupus-like disease 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

• inflammation of the nasal passages, pain in the throat, nose bleed
• allergic reactions
• increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
• headache
• nausea, constipation, wind, indigestion, diarrhoea
• joint pain, muscle pain and back pain
• blood test results that show your liver function can become abnormal

Uncommon: may affect up to 1 in 100 people

• anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)
• having nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)
• hepatitis (liver inflammation)
• rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
• urine tests that are positive for white blood cells

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

• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury

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

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

Not known: frequency cannot be estimated from the available data: Muscle weakness that is constant.

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

• Sexual difficulties
• Depression
• Breathing problems including persistent cough and/or shortness of breath 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme:. By reporting side effects you can help provide more information on the safety of this medicine

5. how to store atorvastatin

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 carton and outer packaging after {EXP}.The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

PVC-PE-PVDC/Aluminium blister – Store below 25°C

Oriented polyamyde-aluminium- polyvinylchloride (PVC) / aluminium foil blister – Do not store above 30°C.

6. contents of the pack and other information

What Atorvastatin contains

• – The active substance(s) is atorvastatin.

Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).

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

Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).

Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).

• – The other ingredient(s) are:

What Atorvastatinlooks like and contents of the pack

10 mg: Atorvastatinfilm-coated tablets are white, round, biconvex tablets with bisection line on one side and debossed 10 on other side. The dimensions of each tablet are approximately 7.0 mm.

20 mg: Atorvastatinfilm-coated tablets are white, round, biconvex tablets with bisection line on one side and debossed 20 on other side. The dimensions of each tablet are approximately 9.0 mm.

40 mg: Atorvastatinfilm-coated tablets are white, round, biconvex tablets with bisection line on one side and debossed 40 on other side. The dimensions of each tablet are approximately 11.0 mm.

80 mg: Atorvastatinfilm-coated tablets are white, oblong, biconvex tablets with bisection line on one side and debossed 80 on other side. The dimensions of each tablet are approximately 18.5 mm.

Atorvastatin film-coated tablets are available in pack sizes of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Laboratorios Liconsa, S.A.

C/ Dulcinea S/N,

28805 Alcala de Henares, Madrid

Spain

PL 23218/0145–0148

Manufacturer:

Laboratorios Liconsa, S.A

Avda. Miralcampo 7

Pohgono Industrial Miralcampo

19200 – Azuqueca de Henares

Guadalajara – Spain

This leaflet was last revised in 09/2021

The duration of treatment with Atorvastatinis determined by your doctor.

Please ask your doctor if you think that the effect of Atorvastatinis too strong or too weak.

If you take more Atorvastatin than you should

If you accidently take too many Atorvastatin tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

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