KRUPLUS 2.5 mg/12.5 mg Tabletki

Treść ulotki

1. KRUPLUS 2.5 mg + 12.5 mg tablets, 5 mg + 25 mg tablets
   1. What is KRUPLUS and what is it used for
   2. What you need to know before taking KRUPLUS
   3. How to take KRUPLUS
   4. Possible side effects
   5. How to store KRUPLUS
   6. Contents of the pack and other information

KRUPLUS 2.5 mg + 12.5 mg tablets, 5 mg + 25 mg tablets

ramipril + hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is KRUPLUS and what is it used for

KRUPLUS is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors).
It works by:

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure
• Relaxing and widening its blood vessels
• Making it easier for its heart to pump blood around the body.

Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” or oral diuretics. It
works by increasing the amount of water (urine) that is produced. This lowers blood
pressure.
KRUPLUS is used to treat high blood pressure (hypertension). The two active ingredients work
together to lower blood pressure. They are used in combination when
treatment with one component alone does not work.

2. What you need to know before taking KRUPLUS

Do not take KRUPLUS:

• If you are allergic to ramipril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to drugs similar to KRUPLUS (other ACE inhibitors or medicines derived from sulfonamide).

Signs of an allergic reaction can be skin rashes, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The signs include itching, skin rash (urticaria), red spots on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing
• If you are in dialysis or are undergoing any other type of blood filtration. Depending on the machinery used, KRUPLUS may not be suitable for you
• If you have severe liver problems
• If you have abnormal levels of salts (calcium, potassium, sodium) in the blood
• If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy(see section “Pregnancy and breastfeeding”)
• If you are breastfeeding (see section “Pregnancy and breastfeeding”)
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

Do not take KRUPLUS if any of the above conditions apply to you. If you are not sure, ask your doctor before taking KRUPLUS.

Warnings and precautions
Talk to your doctor or pharmacist before taking KRUPLUS:

• If you have heart, liver or kidney problems
• If you have lost a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking oral diuretics for a long time or having undergone dialysis)
• If you are about to undergo treatment to reduce the allergy to bee or wasp stings (desensitization)
• If you are about to undergo anesthesia that may be administered for surgery or dental work. It may be necessary to stop treatment with KRUPLUS the day before; ask your doctor for advice
• If you have a high amount of potassium in your blood (highlighted by a blood test)
• If you are taking medicines or are in conditions that may lower sodium levels in the blood. Your doctor may prescribe blood tests at regular intervals, especially to check sodium levels in the blood, especially if you are elderly
• If you are taking medicines called mTOR (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin, as they may increase the risk of angioedema, a severe allergic reaction.
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus
• You must tell your doctor if you think you are pregnant (or could become pregnant). KRUPLUS is not recommended during the first trimester of pregnancy and can cause serious harm to the baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”)
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking KRUPLUS
• If you have blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur within a period ranging from a few hours to weeks

after taking KRUPLUS. This can lead to permanent vision loss if left untreated. If you have previously had an allergy to penicillin or sulfonamide, you may have a higher risk of developing this disorder.

• If you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren” Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the intake of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking IDROTENS, consult a doctor immediately. See also what is reported under "Do not take Kruplus"

For those who play sports: the use of the drug without a therapeutic need constitutes doping and may still result in positive doping tests

Children and adolescents
KRUPLUS is not recommended for children and adolescents under 18 years of age because this medicine has never been used in this age group.
If any of the above conditions occur or you are not sure, ask your doctor before taking KRUPLUS.

Other medicines and KRUPLUS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because KRUPLUS can affect the mechanism of action of some other medicines. Also, some medicines can affect the mechanism of action of KRUPLUS.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere with KRUPLUS by reducing its effectiveness:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, norepinephrine or adrenaline. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These medicines, if taken with KRUPLUS, may increase the likelihood of side effects:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen, indomethacin, aspirin)
• Medicines that can lower the amount of potassium in the blood. These include medicines for constipation, diuretics, amphotericin B (used for fungal infections) and adrenocorticotropic hormone (used to check if your adrenal glands are working properly)
• Cancer medicines (chemotherapy)
• Medicines for heart problems, including heartbeat problems
• Medicines to prevent organ rejection after transplantation such as cyclosporine
• Diuretics such as furosemide
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to make the blood more fluid)
• Steroid medicines for the treatment of inflammation such as prednisolone
• Calcium supplements
• Allopurinol (used to lower uric acid levels in the blood)
• Procainamide (for heartbeat problems)
• Cholestyramine (to reduce the amount of fat in the blood)
• Carbamazepine (for the treatment of epilepsy)
• Heparin (to thin the blood)
• Temsirolimus (for cancer)
• Sirolimus, everolimus (to prevent transplant rejection)
• Vildagliptin (for the treatment of type 2 diabetes).

Your doctor may need to adjust the dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported under "Do not take Kruplus" and “Warnings and precautions”)
Tell your doctor if you are taking any of the following medicines. The mechanism of action of these medicines may be affected by KRUPLUS:

• Diabetes medicines such as oral hypoglycemic agents and insulin. KRUPLUS may lower blood sugar levels. Carefully check your blood sugar levels when taking KRUPLUS.
• Lithium (for psychiatric problems). KRUPLUS may increase the amount of lithium in the blood. Your doctor must carefully monitor the level of lithium in your blood.
• Muscle relaxants
• Quinine (for the treatment of malaria)
• Medicines containing iodine, these may be used in hospital before an X-ray or scan
• Penicillin (for the treatment of infections)
• Blood-thinning medicines to be taken orally (oral anticoagulants) such as warfarin.

If any of the above conditions occur (or you are not sure), ask your doctor before taking KRUPLUS.

Checks
Tell your doctor or pharmacist before taking this medicine.

• If you are having a check for parathyroid function. KRUPLUS may alter the results of the check

KRUPLUS with food and alcohol

• Drinking alcoholic beverages with KRUPLUS may cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking KRUPLUS, discuss this with your doctor. In fact, alcohol increases the effects of blood pressure medications.
• KRUPLUS can be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you are pregnant (or could become pregnant).
You must not take KRUPLUS in the first 12 weeks of pregnancy and must absolutely not take it after the 13th week because its use may be harmful to the baby.
If you become pregnant while taking KRUPLUS, tell your doctor immediately. Before planning a pregnancy, you must switch to another more suitable medicine.
Breastfeeding
You must not take KRUPLUS if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery
You may experience dizziness while taking KRUPLUS. This is more likely when you have just started taking KRUPLUS or have just increased the dose. If this happens, do not drive or use tools or machinery.

3. How to take KRUPLUS

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

How much to take

Treatment of high blood pressure
The doctor will adjust the dose you take until your blood pressure is under control.

Elderly population
The doctor will reduce the initial dose and adjust the treatment more slowly.

Taking this medicine

• Take the medicine by mouth at the same time of day, every day, usually in the morning.
• Swallow the tablets with some liquid.
• Do not break or chew the tablets.

If you take more KRUPLUS than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to
the hospital, have someone accompany you or call an ambulance. Bring the package of the
medicine with you. This is because the doctor needs to know what you have taken.

If you forget to take KRUPLUS

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a missed tablet.

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

4. Possible side effects

Like all medicines, KRUPLUS can cause side effects, although not everybody gets them.
manifest.

Stop taking KRUPLUS and tell your doctor immediately if you notice any serious side effect – you may need urgent medical attention:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or skin rash. This can be a sign of a severe allergic reaction to KRUPLUS.
• Severe skin reactions including skin rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Increased heart rate, irregular or strengthened heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke
• Shortness of breath or cough, fever lasting 2 to 3 days and decreased feeling of hunger. These can be signs of lung problems, including inflammation
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or easy onset of infections, sore throat and fever, feeling tired, weak, dizzy or pale skin. These can be signs of circulatory or bone marrow problems
• Severe stomach pain that can extend to the back. This may be a sign of pancreatitis (inflammation of the pancreas)
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Tell your doctor if any of the following conditions becomes severe or persists for
more than a few days.
Common(may affect up to 1 in 10 people)

• Headache or feeling weak or tired
• Feeling dizzy. This is more likely to happen when treatment with KRUPLUS is just started or you have just increased the dose
• Dry, irritating cough or bronchitis
• Blood tests show a higher than normal sugar level. If you have diabetes, this may worsen
• Blood tests show a higher than normal uric acid or fat level
• Painful, red and swollen joints

Not common(may affect up to 1 in 100 people)

• Skin rash with or without swelling
• Hot flushes, weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly
• Problems with balance (vertigo)
• Itching and unusual skin sensations such as numbness, tingling, prickling, burning or chafing (paresthesia)
• Loss or change of taste
• Sleep problems
• Depressed mood, anxious, more nervous than usual or irritability
• Blocked nose, inflammation of the sinuses (sinusitis), shortness of breath
• Inflammation of the gums (gingivitis), swelling of the mouth
• Red, swollen, watery or itchy eyes
• Tinnitus in the ear
• Blurred vision
• Hair loss
• Chest pain
• Muscle pain
• Constipation, stomach or intestinal pain
• Indigestion or feeling unwell
• Increased amount of urine during the day
• Increased sweating or feeling thirsty than usual
• Loss or decrease of appetite (anorexia), decreased feeling of hunger
• Fast or irregular heartbeat
• Swollen arms and legs. This may be a sign that your body is retaining more water than usual
• Fever
• Impotence in men
• Decreased number of red blood cells, white blood cells and platelets in the blood or hemoglobin concentration, detected by blood tests
• Changes in liver, pancreas or kidney function detected by blood tests
• Blood tests show a lower than normal potassium level.

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

• Feeling unwell, causing diarrhea or heartburn
• Swollen and red tongue or dry mouth
• Blood tests show a higher than normal potassium level.
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known:

• skin and lip cancer (non-melanoma skin cancer)

Other side effects reported:
Tell your doctor if any of the following conditions becomes severe or persists for a time
longer than a few days.

• Difficulty concentrating, feeling restless or confused
• Fingers of the hands and feet that change color when cooled and tingle and hurt when warmed (Raynaud's phenomenon)
• Increased breast volume in men
• Blood clots
• Hearing disorders
• Eyes less moist than usual
• Objects appear yellow
• Dehydration
• Swelling, pain and redness of the cheeks (inflammation of a salivary gland)
• Swelling of the intestine called “intestinal angioedema” and which presents with symptoms such as abdominal pain, vomiting and diarrhea
• Increased sensitivity to the sun
• Severe flaking or scaling of the skin, itching, rash or other skin reactions such as redness of the face or forehead
• Rash or bruising
• Spots on the skin and cold extremities
• Problems with nails (such as loss or separation of the nail from its bed)
• Musculoskeletal stiffness or inability to move the jaw (tetanus)
• Muscle weakness or cramps
• Decreased sexual desire in men and women
• Presence of blood in the urine. This could be a sign of a kidney problem (interstitial nephritis)
• Greater amount of sugar in the urine than normal
• Increased number of white blood cells in the blood (eosinophilia) detected during blood tests
• Too low number of blood cells detected by blood tests (pancytopenia)
• Change in the level of salts such as sodium, calcium, magnesium and chlorine in the blood detected by blood tests
• Slowed or altered reactions
• Change in the perception of smells
• Difficulty breathing or worsening of asthma
• Severe eye pain, blurred vision or vision with halos of light, headache, widespread tearing or nausea and vomiting which may constitute a condition called glaucoma.
• Rapid onset of distant vision reduction (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store KRUPLUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label after Expiry. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What KRUPLUS contains

KRUPLUS 2.5 mg + 12.5 mg tablets
One divisible tablet contains:

The active ingredients are: ramipril 2.5 mg + hydrochlorothiazide 12.5 mg;

The other ingredients are: hypromellose, pregelatinized starch, microcrystalline cellulose and sodium
stearylfumarate.

KRUPLUS 5 mg + 25 mg tablets
One divisible tablet contains

The active ingredients are: ramipril 5 mg + hydrochlorothiazide 25 mg;

The other ingredients are: hypromellose, pregelatinized starch, microcrystalline cellulose and sodium
stearylfumarate.

Description of the appearance of KRUPLUS and contents of the pack
Tablets.

KRUPLUS 2.5 mg + 12.5 mg tablets:pack of 14 divisible tablets in blisters.

KRUPLUS 2.5 mg + 12.5 mg tablets:pack of 28 divisible tablets in blisters.

KRUPLUS 5 mg + 25 mg tablets:pack of 14 divisible tablets in blisters

KRUPLUS 5 mg + 25 mg tablets:pack of 28 divisible tablets in blisters

Marketing Authorisation Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Roma)

Manufacturer
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR) - Italy
November 2021