PRAVASTATIN PHARMA COMBIX 40 mg TABLETS

Pravastatin Sodium

Contents of the prospectus:

1. What is Pravastatin Pharma Combix and what is it used for
2. Before taking Pravastatin Pharma Combix
3. How to take Pravastatin Pharma Combix
4. Possible adverse effects
5. Storage of Pravastatin Pharma Combix
6. Additional information

1. What is Pravastatin Pharma Combix and what is it used for

Pravastatin Pharma Combix 40 mg belongs to the group of medications known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and, as a consequence, reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of the blood vessels, obstructing them.

This situation is known as hardening of the arteries or atherosclerosis, and can lead to:

• chest pain (angina pectoris), when a blood vessel of the heart is partially obstructed
• heart attack (myocardial infarction), when a blood vessel of the heart is completely obstructed
• stroke (cerebrovascular accident) when a blood vessel of the brain is completely obstructed

This medication is indicated in three situations:

In the treatment of high levels of cholesterol and fats in the blood.

Pravastatin Pharma Combix is indicated to decrease high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

The prevention of heart and blood vessel diseases.

• If you have high levels of cholesterol in the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little exercise), Pravastatin Pharma Combix is indicated to reduce the risk of you suffering from a heart or blood vessel problem and decreases the risk of dying from these diseases.

• If you have already suffered a stroke or suffer from chest pain (unstable angina), even with normal cholesterol levels. Pravastatin Pharma Combix is indicated to reduce the risk of you suffering from another heart attack or stroke in the future, and decreases the risk of dying from these diseases.

After an organ transplant.

If you have undergone an organ transplant and are taking medication to prevent your body from rejecting the transplant, Pravastatin Pharma Combix 40 mg is indicated to reduce high levels of fat in the blood.

2. Before taking Pravastatin Pharma Combix

Do not take Pravastatin Pharma Combix 40 mg:

• If you are allergic (hypersensitive) to pravastatin sodium or to any of the other components of this medication (see Additional information).
• If you are pregnant, plan to become pregnant, or are breastfeeding (see "Pregnancy and breastfeeding")
• If you have any liver disease (active liver disease);
• If several blood tests show abnormal liver function (elevated liver enzymes in the blood).

Be especially careful with Pravastatin Pharma Combix 40 mg:

Before taking this treatment, you should consult your doctor if you have or have had any of the following medical problems:

• kidney disease;
• hypothyroidism;
• liver disease or problems with alcohol (drinking large amounts of alcohol);
• muscle disorders caused by a hereditary disease;
• muscle problems caused by another medication belonging to the group of statins (HMG-CoA reductase inhibitors) or belonging to the group known as fibrates (see Taking other medications).
• If you are taking or have taken in the last 7 days a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pravastatin Pharma Combix can cause serious muscle problems (rhabdomyolysis).

If you have had any of these problems or if you are over 70 years old, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to assess the risk of you suffering from muscle adverse effects.

If you experience unexplained muscle cramps or pain during treatment, inform your doctor immediately.

Consult your doctor or pharmacist before taking Pravastatin Pharma Combix if you:

Have severe respiratory failure.

If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).

Also, inform your doctor or pharmacist if you have constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Use of other medications:

When combined with this treatment, the medications mentioned below may increase the risk of muscle problems(see Possible adverse effects). It is important that you inform your doctor if you are being treated with:

• a medication that lowers blood cholesterol levels (fibrates, e.g., gemfibrozil, fenofibrate);
• a medication that lowers the body's defenses (cyclosporin);
• a medication that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin);
• any other medication that lowers blood cholesterol levels (nicotinic acid)
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medication. Your doctor will indicate when you can restart treatment with Pravastatin Pharma Combix. The use of Pravastatin Pharma Combix with fusidic acid can cause serious muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

If you are also using a medication to lower fat levels in your blood (such as a resin like cholestyramine or colestipol), this treatment should be taken at least one hour before or four hours after taking the resin. This is because the resin can affect the absorption of Pravastatin Pharma Combix if these two medications are taken simultaneously.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Taking Pravastatin Pharma Combix 40 mg with food and drinks:

This treatment can be taken with or without food, with a half glass of water.

You should reduce your alcohol consumption to a minimum. If you have doubts about how much alcohol you can drink while taking this medication, you should consult your doctor.

Pregnancy:

Do not take Pravastatin Pharma Combix 40 mg during pregnancy. If you discover that you are pregnant, you should inform your doctor immediately.

Consult your doctor or pharmacist before using any medication.

Breastfeeding:

Pravastatin Pharma Combix 40 mg should not be administered during the breastfeeding period, as this treatment passes into breast milk.

Driving and using machines:

Pravastatin Pharma Combix 40 mg normally does not affect your ability to drive or use machines. However, if you notice symptoms of dizziness, blurred vision, or double vision during treatment, do not drive or use machines until you are sure you can do so.

Important information about some of the components of Pravastatin Pharma Combix 40 mg:

This medication contains lactose.

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

3. How to take Pravastatin Pharma Combix 40

Your doctor will advise you on a low-fat diet, which you should continue until the end of treatment.

Follow the administration instructions for this treatment exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Pravastatin Pharma Combix 40 mg can be taken with or without food, with a half glass of water.

Dose:

Adults

• In the treatment of high levels of cholesterol and fat in the blood: the normal dose is 10-40 mg once a day, preferably at night.
• In the prevention of heart and blood vessel diseases: the normal dose is 40 mg once a day, preferably at night.

Do not exceed the maximum daily dose of 40 mg of pravastatin sodium. Your doctor will determine the appropriate dose for you.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases blood cholesterol levels:

The recommended dose between 8 and 13 years is 10-20 mg once a day, and the recommended dose between 14 and 18 years is 10-40 mg once a day.

After an organ transplant:

Your doctor may prescribe an initial dose of 20 mg once a day. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medication that lowers the body's immune system (cyclosporin), your doctor may prescribe an initial dose of 20 mg once a day. This dose may be adjusted up to 40 mg by your doctor.

If you have severe kidney or liver disease, your doctor may prescribe a lower dose of Pravastatin Pharma Combix.

If you think the effect of this treatment is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment:

Your doctor will indicate the duration of your treatment with Pravastatin Pharma Combix. This medication should be taken regularly for the time recommended by your doctor, even if it is for a long period. Do not stop treatment on your own.

If you take more Pravastatin Pharma Combix 40 mg than you should:

If you have taken more Pravastatin Pharma Combix 40 mg than you should, or if someone has accidentally swallowed some tablets, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pravastatin Pharma Combix 40 mg

If you forget to take a dose, simply take your normal dose when it is time for the next one.

Do not take a double dose to make up for forgotten doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, Pravastatin Pharma Combix 40 mg can have adverse effects, although not everyone will experience them.

Stop taking Pravastatin Pharma Combix 40 mg and inform your doctor immediatelyif you notice unexplained muscle pain or persistent pain, pain on palpation, weakness, or cramps, especially if you do not feel well or have a fever.

In very rare cases, muscle problems can be serious (rhabdomyolysis) and can cause a life-threatening kidney disease.

Severe and sudden allergic reactions such as swelling of the face, lips, tongue, or trachea can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. You should inform your doctor immediately if this happens.

The following adverse effects are uncommon and may affect more than 1 in 1,000 people:

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders, including insomnia
• Eye disorders:blurred vision or double vision
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas
• Hepatobiliary disorders:

Very rare: jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

• Skin and hair disorders:itching, acne, rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss)
• Urinary and genital disorders:changes in urination (such as painful urination, frequent urination, and increased urination at night), and sexual problems
• Muscle and joint disorders:muscle and joint pain

The following adverse effects are very rare and may affect less than 1 in 10,000 people:

• Nervous system disorders:alterations in touch sensation, including burning or tingling, or numbness, which indicates nerve damage.
• Skin disorders:severe skin alteration (lupus-like syndrome);
• Liver disorders: liver or pancreas inflammation; jaundice (recognized by yellowing of the skin and whites of the eyes); rapid destruction of liver cells (fulminant hepatic necrosis);
• Muscle and bone disorders: inflammation of one or more muscles causing pain or muscle weakness (myositis or polymyositis); pain or weakness in muscles, tendon inflammation, sometimes complicated by rupture.
• Altered blood tests: increased transaminases (a group of blood enzymes) that may be a sign of liver problems. Your doctor may want to perform periodic tests to monitor this.

Possible adverse effects:

• Nightmares
• Memory loss
• Depression

Respiratory problems, including persistent cough and/or difficulty breathing or fever

Adverse effects of unknown frequency:

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Muscle rupture.

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pravastatin Pharma Combix

Keep out of the reach and sight of children.

Do not use this treatment after the expiration date that appears on the carton and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Keep in the original packaging to protect it from moisture and light.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the Sigre Collection Point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Pravastatin Pharma Combix 40 mg:

• The active ingredient is pravastatin sodium. Each Pravastatin Pharma Combix tablet contains 40 mg of pravastatin sodium.
• The other components are lactose monohydrate, sodium croscarmellose, magnesium stearate, light magnesium oxide, microcelac 100, povidone K-30, and yellow iron oxide (E172).

Appearance of the product and packaging content:

Pravastatin Pharma Combix 40 mg tablets are presented in the form of a yellow, rectangular, biconvex tablet with rounded edges, without a coating, with the letters "PDT" engraved on one face and the number "40" engraved on the other face.

Pravastatin Pharma Combix 40 mg tablets are packaged in blister packs and in containers of 28 tablets.

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Date of the last revision of this prospectus: March 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/