Dipperam

Package leaflet: Information for the patient

Dipperam, 5 mg + 80 mg, film-coated tablets
Dipperam, 5 mg + 160 mg, film-coated tablets
Dipperam, 10 mg + 160 mg, film-coated tablets
Amlodipine + Valsartan
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents of the leaflet:

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

1. What Dipperam is and what it is used for

Dipperam tablets contain two active substances: amlodipine and valsartan. Both substances help control high blood pressure.
 Amlodipine belongs to a group of substances called calcium channel blockers. It inhibits the influx of calcium ions into the smooth muscle cells of blood vessel walls, thereby preventing blood vessel constriction.
 Valsartan belongs to a group of substances called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan blocks the effects of angiotensin II.
Both active substances prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.
Dipperam is used for the treatment of high blood pressure in adults whose blood pressure is not sufficiently controlled with amlodipine or valsartan alone.

2. Important information before using Dipperam

When not to use Dipperam
if the patient is allergic to amlodipine or to other medicines in the calcium antagonist group. Symptoms
of allergy may include itching, skin redness, or difficulty breathing.
if the patient is allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If in doubt, consult a doctor before using Dipperam.
if the patient has severe liver function disorders or biliary tract disorders, such as biliary cirrhosis or cholestasis.

• if the patient is more than 3 months pregnant (Dipperam should also not be used during early pregnancy - see section "Pregnancy and breastfeeding").
  if the patient has significantly low blood pressure (hypotension).
  if the patient has aortic valve stenosis or is in cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body's cells).
  if the patient has heart failure due to myocardial infarction.
  if the patient has diabetes or kidney function impairment and is taking an antihypertensive medicine containing aliskiren.

If any of the above situations apply, do not take Dipperam and contact your doctor.

Warnings and precautions
Before starting Dipperam, discuss with your doctor if:
the patient has gastrointestinal disorders (vomiting or diarrhoea)
the patient has liver or kidney function disorders
the patient has received a kidney transplant or has renal artery stenosis
the patient has been diagnosed with adrenal gland disorders, i.e. primary hyperaldosteronism
the patient has heart failure or has had a myocardial infarction.
Strictly follow the doctor's recommendations regarding starting treatment. The doctor may also monitor the patient's kidney function.
the patient has heart valve stenosis (aortic or mitral stenosis) or abnormal thickening of the heart muscle (hypertrophic obstructive cardiomyopathy)
the patient previously experienced swelling, especially of the face and throat, when taking other medicines (including angiotensin-converting enzyme inhibitors). If such symptoms occur, discontinue Dipperam immediately and contact your doctor without delay. Dipperam must never be used again.
the patient is taking any of the following medicines for high blood pressure:

• ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disease due to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Dipperam".
If any of the above warnings apply, inform your doctor before taking Dipperam.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Dipperam, discuss this with the doctor. The doctor will decide on further treatment. Do not discontinue Dipperam on your own initiative.

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

Dipperam with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to use. The doctor may recommend dose adjustments and/or additional precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to the following medicines:
ACE inhibitors or aliskiren (see also sections "When not to use Dipperam" and "Warnings and precautions");
diuretics (water tablets, medicines that increase urine production);
lithium (a medicine used to treat certain forms of depression);
potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and other substances that increase blood potassium levels;
certain painkillers, i.e. non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors); the doctor may also monitor kidney function;
antiepileptic medicines (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
St John's wort (Hypericum perforatum);
glyceryl trinitrate ("nitroglycerin") and other nitrates or other vasodilating substances;
medicines used to treat HIV/AIDS infection (e.g. ritonavir, indinavir, nelfinavir);
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
antibiotics (i.e. rifampicin, erythromycin, clarithromycin, telithromycin);
verapamil, diltiazem (medicines used for heart conditions);
simvastatin (a medicine used to reduce high blood cholesterol levels);
dantrolene (a medicine administered by infusion in cases of significant body temperature disturbances);
medicines used to prevent rejection of transplanted organs (cyclosporine).

Dipperam with food and drink
While taking Dipperam, do not eat grapefruit or drink grapefruit juice, as this may increase blood levels of one of the active substances – amlodipine. This could lead to unpredictable intensification of the blood pressure-lowering effect of Dipperam.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Usually, the doctor will recommend discontinuing Dipperam before becoming pregnant or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Dipperam is not recommended during early pregnancy (first 3 months) and must not be taken after the third month of pregnancy, as the medicine taken during this period may seriously harm the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Dipperam is not recommended during breastfeeding. For patients planning to breastfeed, especially of a newborn or premature infant, the doctor may choose a different suitable medicine.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Dipperam may cause dizziness and impair concentration. Do not drive, operate machinery, or perform tasks requiring alertness until you know how you react to the medicine.

3. How to use Dipperam

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 effects.
The usual dose of Dipperam is 1 tablet per day.

• It is best to take the medicine at the same time each day.
• Swallow the tablets with a glass of water.
• Dipperam may be taken during meals or independently of meals. Do not take Dipperam together with grapefruit or grapefruit juice.

Depending on the patient's response to treatment, the physician may recommend a higher or lower dose.
Do not use a dose greater than recommended.
Use of Dipperam in elderly patients (65 years of age or older)
The physician will exercise caution when increasing the dose.
If you have any further doubts regarding the use of this medicine, consult your
physician or pharmacist.
Taking more Dipperam than prescribed
If too many Dipperam tablets have been taken or if someone else has taken the tablets, contact a doctor immediately.
Missing a dose of Dipperam
If a dose is missed, take it as soon as you remember, then take the next tablet at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.
Stopping Dipperam treatment
Stopping treatment with Dipperam may cause worsening of the disease. Do not discontinue taking the medicine without medical advice.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Some symptoms may be serious and may require urgent medical attention.
Such reactions are rare (occurring in fewer than 1 in 1,000 people).
If any of the following symptoms occur, seek immediate medical advice:

• allergic reaction with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling faint or dizzy)

Other possible adverse effects of Dipperam
Common (may occur in fewer than 1 in 10 people):

• flu-like symptoms
• nasal congestion, sore throat and discomfort when swallowing
• headache
• swelling of arms, hands, legs, ankles or feet
• fatigue
• weakness
• skin redness and feeling of warmth in the face and (or) neck

Uncommon (may occur in fewer than 1 in 100 people):

• central dizziness
• nausea and abdominal pain
• dry mouth
• drowsiness, tingling or numbness in hands or feet
• sensation of spinning
• increased heart rate, including palpitations
• dizziness upon standing
• cough
• diarrhoea
• constipation
• rash, skin redness
• joint swelling, back pain
• joint pain

Rare (may occur in fewer than 1 in 1,000 people):

• feeling of restlessness
• ringing in the ears (tinnitus)
• fainting
• passing increased volume of urine or feeling a sudden urge to urinate
• inability to achieve or maintain erection
• feeling of heaviness
• low blood pressure with symptoms such as dizziness, lightheadedness
• excessive sweating
• rash over the entire body
• itching
• muscle cramps

If any of these symptoms are significantly severe, consult a doctor.
Adverse effects reported after administration of amlodipine alone or walsartan alone, which have not
been observed after administration of Dipperam or which occurred more frequently with amlodipine or
walsartan than with Dipperam:
Amlodipine
If any of the following very rare, serious adverse effects occur after taking the medicine, seek
immediate medical advice:

• 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, blistering, peeling and swelling of the skin, 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 with general malaise.

The following adverse effects have been reported. If any effect is bothersome to the patient
or persists for more than one week, contact a doctor.
Common (may occur in fewer than 1 in 10 people):
dizziness, drowsiness, palpitations (awareness of heartbeat), sudden flushing, especially of the face,
ankle swelling (oedema), abdominal pain, nausea.
Uncommon (may occur in 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/rhinorrhoea
due to inflammation of the nasal mucosa (rhinitis), dyspepsia, vomiting, hair loss, excessive sweating,
skin itching, skin discoloration, urinary disturbances, increased need to urinate at night, increased
frequency of urination, inability to achieve erection, discomfort or enlargement of breasts in men, pain,
malaise, muscle pain, muscle cramps, increased or decreased body weight.
Rare (may occur in fewer than 1 in 1,000 people):
confusion.
Very rare (may occur in fewer than 1 in 10,000 people):
decreased white blood cell count, decreased platelet count, which may lead to unusual bruising or
easy bleeding, increased blood glucose levels (hyperglycaemia), gum swelling, abdominal distension
(gastric mucosal inflammation), 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, complex movement disorders involving rigidity,
tremor and (or) difficulty moving.
Walsartan
Frequency unknown (cannot be estimated from available data):
decreased red blood cell count, fever, sore throat or oral ulcers due to infection, spontaneous bleeding
or bruising, high potassium levels in blood, abnormal liver function test results, worsening kidney
function and severe kidney dysfunction, swelling, mainly of the face and throat, muscle pain, rash,
purple-red spots, fever, itching, allergic reaction, blistering of the skin (symptom of a disease called
bullous pemphigoid).
If any of these symptoms occur, seek immediate medical advice.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department for 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dipperam

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Do not use this medicine if there are visible signs of deterioration.
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 package and other information

What Dipperam contains

• The active substances are amlodipine (in the form of amlodipine besylate) and valsartan. Each 5 mg + 80 mg coated tablet contains 5 mg of amlodipine and 80 mg of valsartan.

Each 5 mg + 160 mg coated tablet contains 5 mg of amlodipine and 160 mg of valsartan.
Each 10 mg + 160 mg coated tablet contains 10 mg of amlodipine and 160 mg of valsartan.

The other ingredients are:
Coated tablets 5 mg + 80 mg and 5 mg + 160 mg: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal anhydrous silica, hypromellose type 2910 (3 mPa.s), titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000, talc.
Coated tablets 10 mg + 160 mg: microcrystalline cellulose, crospovidone (type A), magnesium stearate, colloidal anhydrous silica, hypromellose type 2910 (3 mPa.s), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 4000, talc.

What Dipperam looks like and contents of the pack
Dipperam 5 mg + 80 mg
Dark yellow, round coated tablets with bevelled edges, marked with "NVR" on one side and "NV" on the other. Approximate size: 8.2 mm in diameter.

Dipperam 5 mg + 160 mg
Dark yellow, oval coated tablets with bevelled edges, marked with "NVR" on one side and "ECE" on the other. Approximate size: 14.2 mm (width) x 5.7 mm (length).

Dipperam 10 mg + 160 mg
Light yellow, oval coated tablets with bevelled edges, marked with "NVR" on one side and "UIC" on the other. Approximate size: 14.2 mm (width) x 5.7 mm (length).

Pack sizes: 7, 14, 28 or 56 coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers/Importers
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg, Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes 764,
08013 Barcelona, Spain
Novartis Farma S.P.A.
Via Provinciale Schito 131,
80058 Torre Annunziata, Italy

For further information about this medicinal product and its names in the Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel: 22 209 70 00