Impactin Duo 10 mg./10 mg. 28 capsules

What is Impactin Duo and what it is used for:
Impactin 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:

Reduces substances produced in your body that can increase your blood pressure;
Helps relax and expand your blood vessels;
It helps the heart to pump the blood in your body more easily.
Amlodipine acts as:

It relaxes and expands the blood vessels, so the blood can pass through them more easily.
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 medications.

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 can be expressed with itching, reddening of the skin or difficulty in breathing;
if you have had 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 type of blood filtration. Depending on the equipment used, Impactin Duo may not be suitable for you;
if you have kidney problems where 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 evaluate 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.
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 or pharmacist 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 (by vomiting, diarrhea, more sweating than usual;
if you are on a low-salt diet, if you take diuretics (drainage tablets) for a long time or have been on dialysis);
if you are receiving treatment to reduce the allergy to bee or axle sting (desensitization);
if you are going to have an anesthetic. You may be given this in a surgical or dental procedure. You may need to stop treatment with Impactin Duo the day before; talk to your doctor;
if you have an increased amount of potassium in the blood (as determined by a blood test);
if you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus;
if you are taking aliskiren to treat high blood pressure;
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 persistent dry cough for a long time.
If you experience sudden swelling of the lips and face, tongue and throat, neck, arms and legs, difficult to swallow and difficult to breathe, this may be a sign of a severe allergic reaction. It may occur at any time during treatment. If you develop these symptoms, you should tell your doctor immediately.

Children and adolescents
The use of Impactin Duo is not recommended in children and adolescents under 18 due to lack of available information on this population.

Other Drugs and Impactin Duo
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of these medicines. They may weaken the effect of Impactin Duo.

Medicines used to relieve pain and inflammation (eg non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin acetylsalicylic acid);
Medicines used to treat low blood pressure, shock, heart failure, asthma or allergy, such as ephedrine, noradrenaline or adrenaline. Your doctor needs to check your blood pressure;
Rifampicin (an antibiotic for the treatment of tuberculosis);
St John's wort (Hypericum perforatum) - used to treat depression).
Tell your doctor if you are taking any of the following medicines. They can increase the capacity
Tell your doctor if you are taking any of the following medicines. These may increase the chance of side effects if you take them at the same time as Impactin Duo:

Medicines used to relieve pain and inflammation (eg non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and acetyl salicylic acid);
Drugs for the treatment of cancer (chemotherapy);
Medicines used to prevent rejection of organs after grafting, eg ciclosporin;
Diuretics (drainage tablets), for example furosemide and other medicines that can lower blood pressure like aliskiren;
Medicines that can increase the amount of potassium in the blood, for example: spironolactone, triamterene, amiloride, potassium salts and heparin (to thin the blood);
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);
Erythromycin, clarithromycin (antibiotics);
Verapamil, diltiazem (for the treatment of heart disease or high blood pressure);
Dannrol (infusion for treatment of serious abnormalities in body temperature).
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 blood pressure and alcohol can enhance 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 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. Before any 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 operate machinery. 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 10 mg / 10 mg once a day.
Your doctor may change the dose depending on what effect it will have on you.

Elderly patients
Your doctor will lower the starting dose and adjust your dosage slowly.

Use in children and adolescents
Impactin Duo is not recommended for children and adolescents under 18 due to lack of available information about this population.

If you take more than the necessary dose of Impactin Duo
Taking too many capsules can cause a low or even dangerous lowering of blood pressure. You may experience dizziness, fainting, fatigue or weakness. If you lower blood pressure
Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking Impactin Duo and contact your doctor immediately if you notice any of the following serious side effects, as you may need urgent treatment:

Swelling of the face, lips or throat, which prevents swallowing or breathing, as well as itching and rashes. This may be a sign of a severe allergic reaction to Impactin Duo;
Severe skin reactions including rash, mouth sores, worsening of existing skin condition, redness, blistering or skin degradation (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme or other allergic reactions.
The above listed side effects are not known (can not be estimated from the available data).

Tell your doctor immediately if you have:

Accelerated heart rhythm, uneven or severe 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, tightness in the chest, palpitations) or uncommon (increased heart rate, heart attack or stroke);
Dyspnoea or cough. These may be signs of lung problems;
(Such as bleeding from the gums), formation of violet spots on the skin or increased likelihood of infections, sore throat and fever, fatigue, fainting, nausea, vomiting, dizziness, paleness. These may be signs of blood or bone marrow problems;
Stomach 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.
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 (sensation of heart attacks), redness of the face;
swelling of the ankles (edema);
headache or fatigue;
feeling dizzy. It is more likely to occur at the onset of taking Impactin Duo or when receiving higher doses;
fainting, hypotension (too low blood pressure), especially when standing up quickly from a sitting or lying position;
dry irritable cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath;
abdominal pain, stomach or intestinal pain, diarrhea, indigestion, nausea or vomiting;
rash on the skin with or without protruding areas;
chest pain;
spasms or muscle pains;
results of 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 / rash caused by nose inflammation (rhinitis);
changes in bowel movements (including diarrhea or constipation), heartburn, dry mouth;
hair loss, increased sweating, itching of the 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 men or women;
discomfort or breast enlargement in men;
joint or muscle pain, muscle spasms, back pain;
increasing or decreasing weight;
problems in equilibrium (vertigo);
itching and abnormal skin sensations such as: stiffness, numbness, tingling, burning or chills on the skin (paraesthesia), loss of pain sensitivity;
loss or alteration of taste sensations;
sleep problems;
depression, anxiety, more nervousness than ordinary or anxiety;
nasal congestion, difficulty in breathing or worsening of asthma;
swelling in the intestine called "intestinal angioedema" and with symptoms such as abdominal pain, vomiting and diarrhea;
lack or reduced appetite (anorexia);
increased or uneven heart rhythm;
swelling of the hands and feet. This may be a sign that your body holds more water than usual;
fever;
increased number of certain white blood cells (eosinophilia) found in blood tests;
results of blood tests showing changes in liver, pancreas or kidney function.
Rare (affects 1 to 1,000 users):

Feeling of insecurity or confusion;
Flushing and swelling of the tongue;
Severe scalp or peeling of the itchy skin, a rash outbreak;
Nail problems (dropping or peeling
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 sewage system 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. Package Contents and Additional 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 5 mg amlodipine.
Impactin 10 mg / 5 mg hard capsules: Each capsule contains 10 mg ramipril and amlodipine besilate equivalent to 5 mg amlodipine.
Impactin 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).
What Impactin Duo looks like and what it contains
Appearance
Impactin Duo 5 mg / 5 mg hard capsules are: hard gelatin capsules with a opaque cap in pink color and a non-transparent body in white. Capsule contents: 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 contents: white to off-white powder.
Impactin Duo 5 mg / 10 mg hard capsules are hard gelatin capsules with opaque cap in reddish-brown color and opaque body in white. Capsule contents: white to off-white powder.
Impactin 10 mg / 10 mg hard capsules are hard gelatin capsules with a opaque brown cap and a white opaque body. Capsule contents: 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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