VALSARTAN DURBAN 160 mg FILM-COATED TABLETS

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (such as enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

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

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

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

You must inform your doctor if you think you are (or might become) pregnant. Valsartan is not recommended at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see the section on pregnancy).

Other medicines and Valsartan Durban

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

The effect of treatment may be altered if Valsartan is taken with other medicines. It may be necessary to change the dose, take other precautions, or, in some cases, stop taking one of the medicines. This applies to both prescription and non-prescription medicines, especially:

• other medicines that lower blood pressure, especially water pills (diuretics), ACE inhibitors (such as enalapril, lisinopril, etc.), or aliskiren (see also the information under the headings “Do not take Valsartan” and “Warnings and precautions”).
• medicines that increase the amount of potassium in the blood, such as potassium supplements and salt substitutes that contain potassium, potassium-sparing medications, and heparin.
• certain types of pain relievers called non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics (from the rifampicin group), a drug used to protect against rejection in a transplant (cyclosporin), or an antiretroviral drug used to treat HIV/AIDS (ritonavir). These drugs may increase the effect of Valsartan.
• lithium, a medicine used to treat some psychiatric diseases.

Also:

heart attack, it is not recommended to combine with ACE inhibitors(a medication for treating a heart attack).heart failure, it is not recommended to combine with a triple combination of an ACE inhibitor and specific medications for the treatment of your heart failure, known as mineralocorticoid receptor antagonists (MRAs) (such as spironolactone, eplerenone) or beta-blockers (such as metoprolol).

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

Taking Valsartan Durban with food and drinks

You can take Valsartan with or without food.

Pregnancy, breastfeeding, and fertility

• You must inform your doctor if you think you are (or might become) pregnant.Normally, your doctor will advise you to stop taking Valsartan Durban before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of valsartan. Valsartan is not recommended at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see the section on pregnancy).

• Tell your doctor if you are breastfeeding or plan to breastfeed.Valsartan is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, or operating machinery, or carrying out other activities that require concentration, make sure you know how valsartan affects you. Like many other medicines used to treat high blood pressure, in rare cases, Valsartan Durban can cause dizziness and affect your ability to concentrate.

3. How to take Valsartan Durban

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. People with high blood pressure often do not feel unwell. 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 high blood pressure:The recommended dose is 80 mg once daily. In some cases, your doctor may prescribe higher doses (for example, 160 mg or 320 mg). Valsartan Durban can also be taken in combination with another medicine (for example, a diuretic).

Use in children and adolescents (from 6 to less than 18 years of age) with high blood pressure:In patients who weigh less than 35 kg, the recommended initial dose is 40 mg of valsartan once daily. In patients who weigh 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 can be increased to 160 mg and up to a maximum of 320 mg).

Adult patients who have had a recent heart attack:After a heart attack, treatment usually starts at 12 hours, usually 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 to a maximum of 160 mg twice daily. The final dose depends on what you can tolerate.

Valsartan can be taken in combination with other treatments for heart attack, and your doctor will decide what treatment is suitable for you.

Adult patients with heart failure:Treatment usually starts with 40 mg twice daily. Your doctor will gradually increase the dose over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you can tolerate. Valsartan Durban can be taken in combination with other treatments for heart failure, and your doctor will decide what treatment is suitable for you.

You can take Valsartan with or without food. Swallow the medicine with a glass of water.

Take it every day at the same time.

If you take more Valsartan Durban than you should

If you notice a strong 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 Valsartan 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 a forgotten dose.

If you stop taking Valsartan Durban

Stopping your treatment with Valsartan may worsen your condition. Do not stop taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and may need 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
• rash (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 side effects are:

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

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

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

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

• sudden loss of consciousness (syncope)
• feeling that everything is spinning (vertigo)
• severe worsening of kidney function (signs of acute kidney failure)
• muscle spasms, abnormal heart rhythm (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

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

• Intestinal angioedema: inflammation of the intestine that presents 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, pain, and swelling of joints, muscle pain, swelling of lymph nodes, or flu-like symptoms (signs of serum sickness)

• purple spots, fever, itching (signs of vasculitis)
• 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 and red blood cell percentage in the blood (which can lead to anemia in severe cases)
• increase in blood potassium levels (which can cause muscle spasms and abnormal heart rhythm in severe cases)
• increase in liver function values (which can indicate liver damage), including an increase in bilirubin in the blood (which can cause yellowing of the skin and eyes in severe cases)
• increase in blood urea nitrogen and serum creatinine levels (which can indicate abnormal kidney function)
• low sodium levels in the blood (which can cause fatigue, confusion, muscle twitching, or seizures in severe cases)

The frequency of some side effects may vary depending on your disease. For example, side effects such as dizziness and worsening of kidney function were observed less frequently in adult patients treated for high blood pressure than in adult patients treated for heart failure or after a recent heart attack.

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

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 through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Valsartan Durban

Keep at a temperature below 25°C in the original package. Protect from moisture.

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 after 'EXP'. The expiry date refers to the last day of the month shown.

Do not take any Valsartan Durban tablet if you notice that the packaging is damaged or shows visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy or other authorized collection point for medicinal waste. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Valsartán Durban

• The active ingredient 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).

Product Appearance and Packaging Content

Light red, film-coated, scored, oval, and biconvex tablets, with the engraving "L" and "13" on both sides of the score on one face and smooth on the other face (approximate size: 13 x 6.2 mm). The score is only for breaking and facilitating swallowing, but not for dividing into equal doses.

The tablets are presented in blister packs of 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

You can request more information about this medication by contacting the marketing authorization holder.

This medication is authorized in the Member States of the EEA under the following names:

Date of the last revision of this prospectus:08/2020

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