Package Leaflet: Information for the User
Atorvastatina Teva-ratiopharm 10 mg Film-Coated Tablets
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
1. What Atorvastatina Teva-ratiopharm is and what it is used for
2. What you need to know before you take Atorvastatina Teva-ratiopharm
3. How to take Atorvastatina Teva-ratiopharm
4. Possible side effects
5. Storage of Atorvastatina Teva-ratiopharm
6. Contents of the pack and additional information
Atorvastatina Teva-ratiopharm belongs to a group of medicines known as statins, which are medicines that regulate lipids (fats).
Atorvastatina Teva-ratiopharm 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 failed.
If you present a high risk of heart disease, Atorvastatina Teva-ratiopharm may also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.
.
Do not take Atorvastatina Teva-ratiopharm
Warnings and precautions
Consult your doctor, pharmacist or nurse before starting to take Atorvastatina Teva-ratiopharm:
In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (for example rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatina Teva-ratiopharm”.
Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.
While taking this medicine, your doctor will monitor if you have diabetes or risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, overweight and high blood pressure.
Other medicines and atorvastatina Teva-ratiopharm
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.
There are some medicines that may affect the proper functioning of Atorvastatina Teva-ratiopharm or the effects of these medicines may be modified by Atorvastatina Teva-ratiopharm. This type of interaction may reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4:
Taking Atorvastatina Teva-ratiopharm with food and drinks
See section 3 for instructions on how to take Atorvastatina. Please note the following:
Orange juice:
Do not take more than one or two small glasses of orange juice per day because large amounts of orange juice may alter the effects of atorvastatin.
Alcohol:
Avoid drinking large amounts of alcohol while taking this medicine. See details in section 2 “Warnings and precautions”.
Pregnancy and breastfeeding
Do not take atorvastatin if you are pregnant, think you may be pregnant or intend to become pregnant
Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures.
Do not take atorvastatin if you are breastfeeding your child.
The safety of atorvastatin during pregnancy and breastfeeding has not been demonstrated.
Consult your doctor or pharmacist before using any medicine.
Driving and operating machinery
Normally this medicine does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to drive. Do not operate tools or machinery if this medicine affects your ability to operate them.
Atorvastatina Teva-ratiopharm contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is; essentially “sodium-free”.
Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with Atorvastatina Teva-ratiopharm.
The usual initial dose of atorvastatin is 10 mg once a day in adults and children aged 10 years and above. Your doctor may increase it if necessary to reach 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 the day with or without food. However, try to take your tablet every day at the same time.
Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will decide the duration of treatment with Atorvastatina Teva-ratiopharm
Ask your doctor if you think the effect of atorvastatin is too strong or too weak.
If you take more Atorvastatina Teva-ratiopharm than you should
If you accidentally take too many Atorvastatina Teva-ratiopharm tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that the hospital staff can easily identify the medication you have taken.
If you forget to take Atorvastatina Teva-ratiopharm
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 the missed doses.
If you interrupt treatment with Atorvastatina Teva-ratiopharm
If you have any other questions about the use of this medication or want to interrupt treatment, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you notice any of the following side effects or severe symptoms, stop taking these tablets and inform your doctor immediately or go to the nearest hospital emergency service.
Rare: may affect up to 1 in 1,000 people
Muy rare: may affect up to 1 in 10,000 people:
Other possible side effects of Atorvastatina Teva-ratiopharm
Poco frequent: may affect up to 1 in 100 people
Rare:may affect up to 1 in 1,000 people
Muy rare:may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from available data:
The possible side effects of some statins (medicines of the same type):
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Store below30°C.
Do not use Atorvastatina Teva-ratiopharm after the expiration date that appears on the packaging after“CAD”. The expiration date is the last day of the month indicated.
Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.
Composition of Atorvastatina Teva-ratiopharm
The active ingredient is atorvastatina. Each tablet contains 10 mg of atorvastatina, equivalent to 10.3625 mg of atorvastatina calcium.
The other components are:
Appearance of the product and contents of the package
Film-coated tablets.
The tablets are white or almost white, elliptical, biconvex, and smooth.
Each package contains 28 tabletsconditioned in blister or in HDPE bottle (contains desiccant).
Holder of the marketing authorization
Teva Pharma, S.L.U.
C/ Anabel Segura, 11 - Edificio Albatros B, 1st floor.
28108 – Alcobendas (Madrid). Spain.
Responsible for manufacturing
Teva Pharma, S.L.U.
Polígono Malpica, Calle C nº 4.
50016 Zaragoza. Spain.
Last review date of this leaflet: March 2025
“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74043/P_74043.html
Маєте питання щодо цього лікування або ваших симптомів? Зв'яжіться з ліцензованим лікарем для отримання допомоги та персонального догляду.