Impactin Duo 10 mg. / 5 mg. 28 capsules

What is Impactin Duo and what it is used for:

Impactin Duo contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists. Ramipril acts as:
• Decrease substances produced in your body that may increase your blood pressure.
• Helps relax and expand your blood vessels.
• Helps your heart to pump the blood in your body more easily.

Amlodipine acts as:
• Allows and expands the blood vessels so blood can pass through them.

Impactin Duo is used to treat hypertension (high blood pressure) in patients who are adequately controlled with amlodipine and ramipril taken simultaneously at the same doses but as single medicines.

2. What you need to know before taking Impactin Duo

Do not take Impactin Duo:
- if you are allergic to amlodipine, ramipril (active substances), some ACE inhibitors or other calcium antagonists, or any of the other ingredients of this medicine (listed in section 6). This may be itchy, reddened or troubled breathing,
If you have a serious allergic reaction called angioedema, signs include itching, hives (urticaria), red spots on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty in breathing and swallowing.
- If you are on dialysis or some other kind of blood filtration. Depending on the device used, Impactin Duo may not be suitable for you if you have kidney problems in which your blood supply to the kidneys is reduced (renal artery stenosis).
- during the last 6 months of pregnancy (see section "Pregnancy, breast-feeding and fertility").
- if you have diabetes mellitus or impaired kidney function and are being treated with aliskiren to treat high blood pressure.
- if your blood pressure is abnormally low or unstable. Your doctor needs to assess this,

- if you have severe narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart can not deliver enough blood to the body).

- if you suffer from heart failure after a heart attack.

- if you have diabetes or have impaired kidney function and are being treated with a blood pressure lowering drug "containing aliskiren".

Do not take Impactin Duo if any of the above applies to you. If you are not sure, ask your doctor before taking Impactin Duo.

Warnings and precautions.
Talk to your doctor, pharmacist or nurse before taking Impactin Duo. Tell your doctor if any of the following conditions apply to you:
- if you have heart, liver or kidney problems;
- if you have lost a lot of salt or fluid (such as vomiting, diarrhea, more sweating than usual if you are on a low salt diet, if you are taking diuretics (drainage tablets) for a long time or have been on dialysis);
- if you are going to have a treatment to reduce the allergy to bee or axle sting (desensitization);
- if you are taking anesthesia. This can be given to you in a surgical operation or dental procedure. You may have to stop treatment with Impactin Duo the day before; talk to your doctor;
- if you have an increased amount of potassium in the blood (detected by a blood test);
- if you have a collagen vascular disease such as scleroderma or systemic erythematosus
lupus;
- if you are taking any of the following medicines used to treat high blood pressure:

• angiotensin II receptor blocker (ARB) (also known as sartens - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems associated with diabetes.
• Aliskiren.

Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood.

See also the information titled "Do not take Impactin Duo":

- if you have a severe increase in blood pressure (hypertension);
if you are elderly and you need to increase your dose;
- if you have a constant dry cough for a long time;
- if your blood pressure is not low enough. Drugs of this type appear to be less effective in people with black skin;
- if you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling in an area such as the throat) is increased:
• sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to avoid rejection of transplanted organs).

If you experience sudden swelling of the lips and face, tongue and throat, neck, hands and feet, difficult to swallow and difficult to breathe, this may be a sign of a severe allergic reaction. It can occur at any time during treatment. If you develop these
Tell your doctor if you are taking any of the following medicines. They may increase the chance of side effects if you take them at the same time as ImpactinDuo.
- Erythromycin, clarithromycin (antibiotics).
- Trimethoprim and co-trimoxazole also known as trimethoprim / sulfamethoxazole (for infections caused by bacteria).
- Temsirolimus (for cancer) or other cancer medicines (chemotherapy).
- Medicines that are most commonly used to avoid rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See the "Warnings and Precautions" section.
- Tacrolimus (used to control the immune response that allows your body to accept the transplanted organ).
- Medicines used to relieve pain and inflammation (eg non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetyl salicylic acid).
- Diuretics (drainage tablets), for example furosemide.
- Medicines that can increase the amount of potassium in the blood, for example: spironolactone, triamterene, amiloride, potassium salts and heparin (for blood thinning).
- Steroidal anti-inflammatory drugs, for example: prednisolone.
- Allopurinol (used to reduce uric acid in the blood).
- Procainamide (for heart rhythm disturbances).
- Ketoconazole, itraconazole (medicines to treat fungal infections).
- Ritonavir, indinavir, nelfinavir (the so-called protease inhibitors used to treat HIV).
- Verapamil, diltiazem (for the treatment of heart disease or high blood pressure).
- Dantrolene (infusion for treatment of serious abnormalities in body temperature).

Your doctor may need to change your dose and / or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also the information titled "Do not take Impactin Duo" and "Warnings and Precautions").

Tell your doctor if you are taking any of the following medicines. They can be influenced by Impactin Duo:
- Diabetes medicines, such as oral medicines for lowering blood sugar and insulin. Impactin Duo can reduce your blood sugar. Check your blood sugar regularly while taking Impactin Duo.
- Lithium (for mental problems). Impactin Duo can increase the amount of lithium in your blood. The amount of lithium should be closely monitored by your doctor.
- Simvastatin (a cholesterol lowering drug). Impactin Duo may increase the amount of simvastatin in your blood.

If any of the above applies to you (or you are not sure), talk to your doctor before taking Impactin Duo.

Impactin Duo with food, drink and alcohol.
Impactin Duo can be taken before or after a meal.
Taking alcohol with Impactin Duo can cause dizziness or fainting. If you are interested in how much you can drink while taking Impactin Duo, talk to your doctor as medicines used to lower your blood pressure and alcohol can increase your sedative effects.
People taking Impactin Duo should not consume grapefruit or grapefruit juice. The reason for this is that these products may lead to an increase in the blood level of the active ingredient amlodipine, causing an unpredictable blood pressure lowering effect by Impactin Duo.

Pregnancy, breastfeeding and fertility.
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy.
You should not take Impactin Duo during pregnancy.

If you become pregnant while taking Impactin Duo, tell your doctor immediately.

Prior to planned pregnancy, another appropriate treatment should be initiated.

Breastfeeding.
You should not take Impactin Duo if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. Fertility

There is insufficient data on the potential effect on fertility.

Driving and using machines.
Impactin Duo may affect your ability to drive or use machines. If Impactin Duo causes nausea, dizziness or fatigue or causes headaches, do not drive or operate machinery and contact your doctor immediately. This can be observed at the start of treatment or when switching to another medicine.

3. How to take Impactin Duo

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

If you feel that the effect of Impactin Duo is too strong or too weak, talk to your doctor or pharmacist.

Take this medicine orally at the same time each day, before or after a meal.

Swallow the capsules whole with liquid.

Do not take Impactin Duo with grapefruit juice.

Impactin Duo should be taken once a day.

The maximum daily dose is one capsule of 1 mg / 10 mg once a day.

Patients
Tell your doctor immediately if you have:
- Accelerated heart rhythm, irregular or intense heartbeat (palpitations), chest pain, chest tightness or more serious problems including heart attack or stroke. The frequency of these side effects is common (chest pain, chest tightness, palpitations) or uncommon (increased heart beat, heart attack or stroke).
- Shortness of breath or cough. These may be signs of lung problems.
- More bleeding, bleeding that goes beyond usual, any signs of bleeding (such as bleeding from the gums), violet spots on the skin or increased likelihood of infection, sore throat and fever, fatigue, aggravation , dizziness, pallor. These may be signs of blood or bone marrow problems.
Strong pain in the stomach that can reach the back. This may be a sign of pancreatitis (inflammation of the pancreas). This is an uncommon side effect.
- Fever, chills, fatigue, lack of appetite, stomach pain, malaise, yellowing of the skin or eyes (jaundice). These may be signs of liver problems, such as liver inflammation (hepatitis) or hepatic impairment. The frequency of this side effect is unknown (can not be estimated from the available data).

Other side effects are:
Please tell your doctor if any of the following reactions become serious or persist for more than a few days. ^ -

Common (affecting between 1 and 10 users)
- drowsiness (especially at the beginning of treatment)
- palpitations (a feeling of heartbeat), redness of the face
- swelling of the ankles (edema)
- headache or fatigue
- Feeling dizzy. It is more likely to occur at the start of taking Impactin Duo or taking higher doses
- fainting, hypotension (too low blood pressure), especially when getting up quickly from a sitting or lying position
- dry irritant cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath abdominal pain, stomach or intestinal pain, diarrhea, indigestion, nausea or vomiting
- Skin rash with or without protruding areas
- chest pain
- spasms or muscle pains
- Results from blood tests showing more potassium than usual in your blood

Uncommon (affecting between 1 and 100 users)
- mood swings, insomnia
- trembling, weakness, pain, malaise
- visual disturbances, double vision, blurred vision, eye watery
- sneezing / runny nose caused by inflammation of the nose (rhinitis)
- changes in bowel movements (including diarrhea or constipation), heartburn, dry mouth
- hair loss, increased sweating, itchy skin, red spots on the skin, depigmentation of the skin
- urinary disorder, increased need for urination, especially at night, increased urination
- Inability to get erections, sexual inability in men, reduced sexual desire in males or females
- Discomfort or breast enlargement in men
- joint or muscle pain, muscle spasms, back pain
- increase or decrease in weight
- problems in equilibrium (vertigo)
- pruritus and abnormal skin sensations such as stiffness, numbness, tingling, burning or chills on the skin (paraesthesia), loss of pain sensitivity
- loss or change of taste sensations
- Sleep problems
- anxiety, anxiety, more nervousness than usual or anxiety
- blocked nose, difficulty in breathing or worsening of asthma
- swelling in the intestines called "intestinal angioedema" and with symptoms such as abdominal pain, vomiting and diarrhea
- lack or reduced appetite (anorexia)
- rapid or irregular heartbeat
- swelling of the hands and feet. This may be a sign that your body holds more water than usual
- fever
- an increased number of some white blood cells (eosinophilia) found in blood tests
- blood test results showing changes in liver, pancreas or kidney function.

Rare (affecting between 1 and 1,000 users)
- A feeling of insecurity or confusion
- Flushing and swelling of the tongue
- Severe scaling or peeling of the skin, itchy, protruding rash
- Nail problems (dropping or peeling from his bed)
- Skin rash or bruising
- Urticaria
- Skin patches and cold limbs
- Flushing, itching, swelling or wetting of the eyes
- Hearing disturbance
- Blood test results show reduced red blood cell count, white blood cells or platelets or decrease in hemoglobin

Very rare (affects less than 1 user in 10,000)
- More sensitivity to sunlight than usual
- Extremely high blood sugar (hyperglycaemia)
- Swelling of the gums
- Swollen stomach (gastritis)
- Impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
- Increased tension in muscles
- Inflammation of 
How to store Impactin Duo

Store below 30 ° C.
Store in the original package in order to protect from light. Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton (year / month). The expiry date refers to the last day of that month. Do not dispose of medicines in the sewer or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and further information What Impactin Duo contains

Active substances are:

Impactin Duo 5 mg / 5 mg hard capsules: Each capsule contains 5 mg ramipril and amlodipine besylate equivalent to S mg of amlodipine.

Impactin 10 mg / 5 mg hard capsules: Each capsule contains 10 mg ramipril and amlodipine besylate, equivalent to 5 mg amlodipine.

Impactin Duo 5 mg / 10 mg hard capsules: Each capsule contains 5 mg ramipril and amlodipine besylate equivalent to 10 mg amlodipine.

Impactin 10 mg / 10 mg hard capsules: Each capsule contains 10 mg ramipril and amlodipine besylate equivalent to 10 mg amlodipine. The other ingredients are:

cellulose, microcrystalline,
calcium hydrogen phosphate, anhydrous,
starch, pregelatinized,
starch, pregelatinized, low moisture,
sodium starch glycolate (type A),
sodium stearyl fumarate,
red iron oxide (E172),
titanium dioxide (E171),
gelatin,
yellow iron oxide (E172), (10 mg / 10 mg), black iron oxide (E172), (10 mg / 10 mg).

How impressive the Impactin Duo and what the package contains.

Appearance.
Impactin Duo 5 mg / 5 mg hard capsules are hard gelatin capsules with opaque cap in pink color and opaque body in white. Capsule content: white to off-white powder. Impactin 10 mg / 5 mg hard capsules are hard gelatin capsules with opaque cap in dark pink and opaque body in white. Capsule content: white to off-white powder. Impactin Duo 5 mg / 10 mg hard capsules are hard gelatin capsules with a opaque cap in reddish-brown color and a non-transparent body in white. Capsule content: white to off-white powder.

Impactin 10 mg / 10 mg hard capsules are hard gelatin capsules with opaque __ latch in brown color and opaque body in white. Capsule content: white to off-white powder.

Package.

Impactin Duo is available in blister packs of 28,30, 32, 56, 60, 90, 91, 96, 98 or 100 capsules. Not all types of packaging can be put on sale in the country.

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