Wamlox

Package leaflet: Information for the user

Wamlox, 5 mg + 80 mg, film-coated tablets
Wamlox, 5 mg + 160 mg, film-coated tablets
Wamlox, 10 mg + 160 mg, film-coated tablets
amlodipine + valsartan
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Wamlox is and what it is used for
Wamlox contains two active substances: amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of medicines called calcium channel blockers. It prevents calcium ions from entering the walls of blood vessels, which helps prevent blood vessel constriction.
• Valsartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is produced in the human body and causes blood vessels to constrict, thereby increasing blood pressure. Valsartan blocks the action of angiotensin II.

This means both substances help prevent constriction of blood vessels. As a result, blood vessels relax and blood pressure decreases.
Wamlox is used to treat high blood pressure in adult patients whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. What you need to know before taking Wamlox

Do not take Wamlox if:

• you are allergic to amlodipine or other calcium channel blockers – symptoms may include itching, skin redness, or breathing difficulties;
• you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6) – if you suspect you may be allergic, inform your doctor before taking Wamlox;
• you have severe liver or biliary tract diseases, such as biliary cirrhosis or cholestasis;
• during the third trimester of pregnancy (you should also avoid using Wamlox in early pregnancy; see section "Pregnancy");
• you have significantly low blood pressure (hypotension);
• you have aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart cannot supply enough blood to the body's cells);
• you have heart failure following a heart attack;
• you have high blood sugar and type 2 diabetes (also called non-insulin-dependent diabetes), or have kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, do not take Wamlox and speak to your doctor.
Warnings and precautions
Before starting Wamlox, discuss with your doctor if:

• you have gastrointestinal disorders (e.g. vomiting, diarrhoea);
• you have liver or kidney disease;
• you have had a kidney transplant or have renal artery stenosis;
• you have an adrenal gland disorder called primary hyperaldosteronism;
• you have had heart failure or a previous heart attack – you must strictly follow your doctor’s advice regarding the starting dose; your doctor may also check your kidney function;
• you have heart valve narrowing (aortic or mitral valve stenosis) or thickened heart muscle (hypertrophic cardiomyopathy with obstructive outflow);
• you have previously experienced swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) – if such symptoms occur, stop taking Wamlox immediately, contact your doctor, and never take Wamlox again;
• you are taking any of the following medicines for high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems due to diabetes,
  • aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "Do not take Wamlox if".
If any of the above apply to you, tell your doctor before taking Wamlox.
If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Wamlox, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Wamlox on your own.

Children and adolescents
Wamlox is not recommended for use in children and adolescents (under 18 years of age).

Other medicines and Wamlox
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Your doctor may need to adjust the dose and/or take other precautions. In some cases, one of the medicines may need to be discontinued. This particularly applies to the following medicines:

• other blood pressure-lowering medicines, including ACE inhibitors or aliskiren (see also sections "Do not take Wamlox if" and "Warnings and precautions");
• diuretics (also called water tablets, which increase urine output);
• lithium (a medicine used to treat depression);
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and other substances that may increase potassium levels;
• certain painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors – your doctor may recommend checking your kidney function;
• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John’s wort (Hypericum perforatum);
• nitroglycerin and other nitrates or other vasodilating substances;
• medicines used in HIV/AIDS treatment (e.g. ritonavir, indinavir, nelfinavir);
• antifungal medicines (e.g. ketoconazole, itraconazole);
• antibiotics (medicines used to treat bacterial infections), such as rifampicin, erythromycin, clarithromycin, telithromycin;
• verapamil, diltiazem (medicines used for heart conditions);
• simvastatin (a medicine used to reduce high cholesterol levels in the blood);
• dantrolene (intravenous, used in severe temperature disorders);
• medicines used to prevent rejection of transplanted organs (cyclosporine, tacrolimus).

Wamlox with food and drink
Patients taking Wamlox should not eat grapefruit or drink grapefruit juice, as both grapefruit and grapefruit juice may increase blood levels of the active substance
amlodipine, which could lead to unpredictable intensification of Wamlox’s blood pressure-lowering effect.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect you are pregnant or are planning a pregnancy. Your doctor will usually advise stopping Wamlox before planning pregnancy or immediately after confirming pregnancy, and will recommend an alternative medicine. Wamlox is not recommended during early pregnancy (first 3 months) and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 3 months of pregnancy.
Breastfeeding
Small amounts of amlodipine have been shown to pass into human milk. Inform your doctor if you are breastfeeding or planning to breastfeed. Wamlox is not recommended during breastfeeding. Your doctor may recommend alternative treatment if you wish to breastfeed, especially if you have a newborn or premature infant.
Always consult your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine may cause dizziness, which could impair your ability to concentrate. Therefore, do not drive, operate machinery, or perform any activity requiring mental alertness until you know how this medicine affects you.

Wamlox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Wamlox

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor. This will help achieve the best treatment outcomes and reduce the risk of adverse
reactions.
The usual dose of Wamlox is 1 tablet per day.

• It is recommended to take the medicine at the same time every day.
• Tablets should be swallowed with a glass of water.
• Wamlox may be taken during or regardless of meals. Do not take Wamlox together with grapefruit or grapefruit juice.

Depending on the response to treatment, the doctor may recommend a higher or lower dose of
the medicine.
Do not use a higher dose than recommended.
Use of Wamlox in elderly patients (aged 65 years and above)
The doctor will exercise caution when increasing the dose.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.
Taking more Wamlox than recommended
If too many Wamlox tablets have been taken or if someone else accidentally takes the tablets,
seek immediate medical advice.
Breathlessness due to fluid accumulation in the lungs (pulmonary oedema) may occur up to
24–48 hours after taking the medicine.
Missing a dose of Wamlox
If the patient forgets to take the medicine, it should be taken as soon as possible. The next dose
should be taken at the usual time. However, if it is almost time for the next dose, the missed
dose should be skipped. Do not take a double dose to make up for the missed dose.
Stopping Wamlox treatment
Stopping Wamlox may cause worsening of the disease. Do not discontinue the medicine unless
instructed by the doctor.
If you have any further questions regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention:
Severe adverse reactions have occurred in a few patients (may affect fewer than 1 in 1,000 people).
If any of the following symptoms occur, contact a doctor immediately:
Allergic reaction with symptoms such as rash, itching, facial swelling, swelling of the lips or tongue,
difficulty breathing, low blood pressure (feeling weak, "emptiness" in the head).

Other possible adverse reactions of Wamlox:
Common (may affect fewer than 1 in 10 people): Flu-like illness; nasal congestion, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); redness and feeling of warmth in the face and (or) neck.
Uncommon (may affect fewer than 1 in 100 people): Dizziness; nausea and abdominal pain; dryness of the oral mucosa; drowsiness, tingling or numbness in hands or feet; vertigo, rapid heartbeat including palpitations; cough; diarrhoea; constipation; skin rash, skin redness; joint swelling, back pain; joint pain.
Rare (may affect fewer than 1 in 1,000 people): Feeling of anxiety; tinnitus (ringing in the ears); fainting; increased urination or feeling a stronger urge to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head; excessive sweating; rash over the entire body; itching; muscle cramps.
If any of these symptoms worsen, inform your doctor.

Adverse reactions reported after administration of amlodipine or valsartan alone, which have not been observed after administration of Wamlox or which have been observed with higher frequency after administration of amlodipine or valsartan compared to Wamlox:

Amlodipine
If any of the following very rare, serious adverse reactions occur after taking the medicine, contact your doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing;
• swelling of eyelids, face or lips;
• swelling of the tongue and throat causing significant breathing difficulties;
• severe skin reactions, including intense rash, urticaria, generalized skin redness, severe itching, blister formation, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions;
• myocardial infarction, cardiac arrhythmias;
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by a very poor general condition.

The following adverse reactions have been reported. If any adverse reaction is troublesome to the patient or persists for more than one week, contact a doctor.
Common (may affect fewer than 1 in 10 people): dizziness, drowsiness; palpitations (awareness of heartbeat); sudden flushing; swelling around the ankles (oedema); abdominal pain, nausea.
Uncommon (may affect fewer than 1 in 100 people): mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, lack of pain sensation; visual disturbances, worsening of vision, tinnitus; low blood pressure; sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting; hair loss, increased sweating, skin itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of breasts in men, pain, malaise, muscle pain, muscle cramps; weight gain or weight loss.
Rare (may affect fewer than 1 in 1,000 people): disorientation.
Very rare (may affect fewer than 1 in 10,000 people): decrease in white blood cell count, decrease in platelet count, which may lead to unusual bruising and easier bleeding; increased blood glucose levels (hyperglycaemia); gum swelling, abdominal bloating (dyspepsia); liver function abnormalities, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in certain blood tests; increased muscle tone; vasculitis, often with skin rash, photosensitivity.
Unknown frequency (cannot be estimated from available data): tremor, rigidity, mask-like facial expression, slowed movements, shuffling gait, unsteady walk.

Valsartan
Very rare (may affect fewer than 1 in 10,000 people): Angioedema of the intestine: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Unknown frequency (cannot be estimated from available data): decreased number of red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; kidney function disorders and kidney failure; swelling, mainly of the face and throat; muscle pain; rash, purple-red spots; fever; itching; allergic reactions, blistering of the skin (symptoms of a disease called bullous pemphigoid).
If any of these symptoms occur, inform your doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Wamlox medicine

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Wamlox contains

• The active substances are amlodipine and valsartan.
  Wamlox 5 mg + 80 mg, coated tablet
  Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
  Wamlox 5 mg + 160 mg, coated tablet
  Each tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
  Wamlox 10 mg + 160 mg, coated tablet
  Each tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.

• Other ingredients are:

  • tablet core: microcrystalline cellulose; magnesium stearate, sodium croscarmellose, povidone K25, sodium lauryl sulfate, mannitol and colloidal anhydrous silica.
  • coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc and iron oxide yellow (E 172).
    See section 2: "Wamlox contains sodium".

What Wamlox looks like and contents of the pack
Wamlox 5 mg + 80 mg, coated tablets
Dark yellow, round, slightly biconvex coated tablets with bevelled edges, possibly with darker specks (tablet diameter: 8 mm, thickness 3.0 mm – 4.3 mm).

Wamlox 5 mg + 160 mg, coated tablets
Dark yellow, oval, biconvex coated tablets, possibly with darker specks (tablet dimensions: 13 mm x 8 mm, thickness: 3.8 mm – 5.4 mm).

Wamlox 10 mg + 160 mg, coated tablets
Pale, dark yellow, oval, biconvex coated tablets (tablet dimensions: 13 mm x 8 mm, thickness: 3.8 mm – 5.4 mm).

Cartons containing 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 coated tablets in blisters OPA/Aluminium/PVC/Aluminium.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA – FARMA d.o.o., V.Holjevca 20/E, 10450 Jastrebarsko, Croatia

This medicinal product is authorised in the European Economic Area under the following names: