Valsartan Durban 160 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Valsartán Durban 160 mg film-coated tablets EFG

Valsartan

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Valsartán Durban is and what it is used for
2. What you need to know before taking Valsartán Durban
3. How to take Valsartán Durban
4. Possible adverse effects
5. How to store Valsartán Durban
6. Contents of the pack and other information

1. What Valsartán Durban is and what it is used for

This medicine contains the active substance: Valsartan. Valsartan belongs to a class of medicines known as angiotensin II receptor antagonists, which help control high blood pressure. Angiotensin II is a substance produced by the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartán Durban blocks the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.

Valsartán Durban 160 mg film-coated tablets EFG can be used to treat three different conditions:

• To treat high blood pressure in adults and in children and adolescents aged 6 to less than 18 years. High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, potentially leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of these complications.
• To treat adult patients after a recent heart attack. Here, "recent" means between 12 hours and 10 days.
• To treat symptomatic heart failure in adult patients. Valsartán Durban is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (a medication used to treat heart failure) cannot be used, or it may be added to ACE inhibitors when other heart failure treatments are not possible.

Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This occurs when the heart muscle cannot pump blood strongly enough to supply the body's needs.

2. What you need to know before taking Valsartán Durban

Do not take Valsartán Durban:

• if you are allergic (hypersensitive) to valsartan or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver disease;
• if you are more than three months pregnant (it is also better to avoid Valsartán during the first months of pregnancy – see section on Pregnancy);
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to you, inform your doctor and do not take Valsartán.

Warnings and precautions

Talk to your doctor before taking Valsartán Durban:

• if you have liver disease;
• if you have severe kidney disease or are on dialysis;
• if you suffer from renal artery stenosis;
• if you have recently undergone a kidney transplant (received a new kidney);
• if you have another serious heart condition other than heart failure or heart attack.

If you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you experience these symptoms while taking Valsartán, stop treatment with Valsartán immediately and never take it again. See also section 4 “Possible side effects”.

• if you are taking medicines that increase blood potassium levels, such as potassium supplements and potassium-containing salt substitutes, potassium-sparing medicines, or heparin. Regular monitoring of blood potassium levels may be necessary.

• if you suffer from aldosteronism. This is a condition in which your adrenal glands produce excessive amounts of the hormone aldosterone. If this applies to you, valsartan is not recommended.

• if you have lost a large amount of fluid (dehydration) due to diarrhea, vomiting, or high doses of diuretics (medicines that increase urine elimination).

• if you are taking any of the following medicines used to treat hypertension (high blood pressure):

• an angiotensin-converting enzyme inhibitor (ACEI) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;

• aliskiren.

• if you are being treated with an ACEI together with other specific medicines for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol).

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Valsartán Durban”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Valsartán. Your doctor will decide whether you need additional treatment. Do not stop taking Valsartán on your own.

You must inform your doctor if you think you are (or could be) pregnant. Valsartán is not recommended in early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see the section on Pregnancy).

Other medicines and Valsartán Durban

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment may be altered if Valsartán is taken with other medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases, discontinue one of the medicines. This applies to both prescription and over-the-counter medicines, especially:

• other medicines that lower blood pressure, particularly diuretic tablets (water pills), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also information under the headings “Do not take Valsartán” and “Warnings and precautions”);
• medicines that increase blood potassium levels, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• certain types of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs);
• some antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartán;
• lithium, a medicine used to treat certain psychiatric disorders.

Also:

• if you are being treated after a heart attack, combination with ACE inhibitors (a medication used to treat heart attack) is not recommended;
• if you are being treated for heart failure, triple combination with an ACE inhibitor and medicines specifically used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g., spironolactone, eplerenone) or beta-blockers (e.g., metoprolol), is not recommended.

Your doctor may need to adjust your dose and/or take other precautions.

Administration of Valsartán Durban with food and drink

You may take Valsartán with or without food.

Pregnancy, breastfeeding, and fertility

• You must inform your doctor if you think you are (or could become) pregnant. Your doctor will usually advise you to stop taking Valsartán Durban before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of valsartan. Valsartán is not recommended during early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

• Inform your doctor if you are breastfeeding or plan to breastfeed. Valsartán is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and use of machines

Before driving, operating tools, handling machinery, or engaging in other activities requiring concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, Valsartán Durban may rarely cause dizziness and affect your ability to concentrate.

3. How to take Valsartán Durban

Always follow exactly the instructions for use of this medicine given by your doctor, in order to achieve the best results and reduce the risk of adverse effects. If in doubt, consult your doctor or pharmacist. People with high blood pressure usually do not notice any signs of this condition. Many may feel fine. For this reason, it is very important that you attend your medical appointments even if you feel well.

Adult patients with arterial hypertension: The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). Valsartán Durban may also be combined with another medicine (for example, a diuretic).

Use in children and adolescents (from 6 to less than 18 years of age) with arterial hypertension: In patients weighing less than 35 kg, the recommended initial dose is 40 mg of valsartan once daily. In patients weighing 35 kg or more, the recommended initial dose is 80 mg of valsartan once daily.

In some cases, your doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Adult patients who have recently suffered a heart attack: After a heart attack, treatment is usually started within 12 hours, typically with a low dose of 20 mg twice daily. To obtain the 20 mg dose, the 40 mg tablet is divided. Your doctor will gradually increase this dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on what you can tolerate.

Valsartán may be administered together with other treatments for heart attack, and your doctor will decide which treatment is appropriate for you.

Adult patients with heart failure: Treatment is usually initiated with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks up to a maximum of 160 mg twice daily. The final dose depends on what you can tolerate. Valsartán Durban may be administered together with other treatments for heart failure, and your doctor will decide which treatment is appropriate for you.

You may take Valsartán with or without food. Swallow the medicine with a glass of water.

Take it every day at the same time.

If you take more Valsartán Durban than you should

If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

If you forget to take Valsartán Durban

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for the missed dose.

If you stop taking Valsartán Durban

Stopping your treatment with Valsartán may cause your condition to worsen. Do not stop taking this medicine unless your doctor tells you to do so.

If you have further questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Some adverse effects can be serious and may require immediate medical attention:

You may experience symptoms of angioedema (a specific allergic reaction), such as

• swelling of the face, lips, tongue, or throat
• difficulty breathing or swallowing
• rashes (hives), itching

If you experience any of these symptoms, stop taking Valsartan and contact your doctor immediately (see also section 2 “Warnings and precautions”)

Other adverse effects are:

Common (may affect up to 1 in 10 people):

• dizziness
• low blood pressure with or without symptoms, such as dizziness and fainting upon standing
• worsening of kidney function (signs of renal failure)

Uncommon (may affect up to 1 in 100 people):

• angioedema (see the section “some symptoms that may be serious and require immediate medical attention”)

• sudden loss of consciousness (syncope)

• sensation that everything is spinning (vertigo)

• severe deterioration of kidney function (signs of acute renal failure)

• muscle spasms, irregular heartbeat (signs of hyperkalemia)

• shortness of breath, difficulty breathing while lying down, swelling of feet or legs (signs of heart failure)

• headache

• cough

• abdominal pain

• nausea

• diarrhea

• fatigue

• weakness

• Very rare (may affect up to 1 in 10,000 people)

• Intestinal angioedema: inflammation of the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (cannot be estimated from the available data):

• Blisters on the skin (sign of bullous dermatitis)

  • Allergic reactions may occur, such as rash, itching, or hives; symptoms of fever, joint pain and swelling, muscle aches, swollen lymph nodes, or flu-like symptoms (signs of serum sickness)

• Purple spots, fever, itching (signs of blood vessel inflammation known as vasculitis)

• Uncommon bleeding or bruising (signs of thrombocytopenia)

• Muscle pain (myalgia)

• Fever, sore throat, or mouth ulcers due to infections (symptoms of low white blood cell count known as neutropenia)

• Decrease in hemoglobin levels and reduced percentage of red blood cells in the blood (which may lead to anemia in severe cases)

• Increased blood potassium levels (which may cause muscle spasms and abnormal heart rhythm in severe cases)

• Increased liver function test values (which may indicate liver damage), including elevated blood bilirubin levels (which may cause yellowing of the skin and eyes in severe cases)

• Increased blood urea nitrogen and serum creatinine levels (which may indicate abnormal kidney function)

• Low blood sodium levels (which may cause fatigue, confusion, muscle fasciculations or spasms, or seizures in severe cases)

The frequency of some adverse effects may vary depending on your condition. For example, adverse effects such as dizziness and impaired kidney function were observed less frequently in adult patients treated for hypertension than in adult patients treated for heart failure or after a recent heart attack.

Adverse effects in children and adolescents are similar to those observed in adults.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valsartán Durban

Store below 25 °C in the original packaging. Protect from moisture.

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

Do not use this medicine after the expiry date stated on the packaging after 'Exp'. The expiry date refers to the last day of the month indicated.

Do not take any Valsartán Durban tablets if you notice that the packaging is damaged or if there are visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy or at any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Valsartán Durban

• The active substance is valsartan.
• The other components are microcrystalline cellulose, crospovidone (type A), colloidal silicon dioxide, magnesium stearate.
• The tablet coating contains hypromellose 6 cp (E464), titanium dioxide (E171), Macrogol 8000, yellow iron oxide (E172) and red iron oxide (E172).

Appearance of the product and contents of the package

Light red film-coated tablets, scored, oval and biconvex, engraved with “L” and “13” on both sides of the score line on one side, and smooth on the other side (approximate size: 13 x 6.2 mm). The score is intended only to facilitate breaking the tablet and swallowing, but not for dividing it into equal doses.

The tablets are available in blister packs containing 7, 14, 28, 56, 98 and 280 film-coated tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Laboratorios Francisco Durbán S.A.

Polígono Ind. La Redonda, c/ IX, nº 2

04710 El Ejido ALMERÍA

Spain

Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

or

Netpharmalab Consulting Services

Carretera de Fuencarral, 22

28108 – Alcobendas, Madrid

Spain

or

Synoptis Industrial Sp. z.o.o.

Nl. Rabowicka 15

62-020 Swarzedz

Poland

For further information about this medicinal product, please contact the Marketing Authorization Holder.

This medicinal product is authorized in the EEA Member States under the following names:

Date of the most recent review of this leaflet: 08/2020

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.