Annin Co 12.5 mg/25 mg Film-Coated Tablets

ANNIN CO is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure. ANNIN CO is indicated for the treatment of essential hypertension (high blood pressure).

Do not take ANNIN CO:

• If you are hypersensitive (allergic) to losartan, hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously been treated with a medication in the same group of medicines as ANNIN CO (angiotensin receptor antagonists) or with a medication in the group of medicines known as ACE inhibitors and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty in swallowing or breathing.
• If you have severely impaired liver function.
• If you have low potassium, low sodium or high calcium levels which cannot be corrected by treatment.
• If you have hereditary or idiopathic angioedema (swelling of the face, lips, mouth, tongue or throat with or without difficulty in swallowing or breathing).
• If you have hypertrophic obstructive cardiomyopathy, a heart disorder in which the walls of the ventricles (lower heart chambers) thicken (hypertrophy) and become stiff and the thickened muscle blocks the flow of blood out of the heart.
• If you have severely impaired kidney function or your kidneys are not producing any urine.
• If you have narrowing of the blood vessels to both kidneys or to a single kidney.
• If you have aortic stenosis, a narrowing of the aortic valve opening between the left ventricle (large pumping chamber of the heart) and the aorta (the main artery leading away from the heart).
• If you are taking diuretics (water pills) that cause your body to retain potassium such as spironolactone, triamterene and amiloride.
• If you have porphyria.
• Thiazide water tablets in (fixed dose) combination as with ANNIN CO should not be given to patients with Addison's disease (a long-term endocrine disorder in which the adrenal glands do not produce enough steroid hormones). This therapy should also not be used in patients with severe kidney disease or patients not passing urine, and in patients who show allergy to other sulphonamide-derived medicines (ask your doctor if you are not sure what sulphonamide-derived medicines are).
• If you are pregnant or breastfeeding (see Pregnancy and Breastfeeding).
• If you have liver disease.
• The concomitant use with antibiotics that belong in the class “fluoroquinolones” should be avoided.
• The concomitant use of ANNIN CO with aliskiren-containing products should be avoided.

Take special care with ANNIN CO:

Talk to your doctor, pharmacist or nurse before taking ANNIN CO. You must tell your doctor if you think you are (or might become) pregnant. ANNIN CO is not recommended in pregnancy, and must not be taken if you are pregnant, as it may cause serious harm to your baby. It is important to tell your doctor before taking ANNIN CO:

• If you have previously suffered from swelling of the face, lips, throat or tongue.
• If you take diuretics (water pills).
• If you are on a salt restricted diet.

Do not share medicines prescribed for you with any other person. Always take ANNIN CO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with ANNIN CO will last. If you have the impression that the effect of ANNIN CO is too strong or too weak, talk to your doctor or pharmacist.

Taking ANNIN CO with food and drink: ANNIN CO tablets may be taken with or without food.

Adult dose: The maximum dose is one tablet of ANNIN CO (100 mg losartan potassium and 25 mg hydrochlorothiazide) once daily. The maximum antihypertensive effect is attained within three weeks after initiation of therapy. Try to take ANNIN CO daily as prescribed. However, if you miss a dose, do not take an extra dose. Just resume your usual schedule.

Paediatric Use: Safety and efficacy in children has not been established. Your doctor will tell you how long your treatment with ANNIN CO will last. Do not stop treatment early because this may lead to reoccurrence of your condition. If you have the impression that the effect of ANNIN CO is too strong or too weak, tell your doctor or pharmacist.

ANNIN CO can have side effects: Not all side effects reported for ANNIN CO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking ANNIN CO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing). This is a serious side effect. You may need urgent medical attention or hospitalisation. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ANNIN CO. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• The following side effects occur frequently:
• Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder
• Diarrhoea, abdominal pain, nausea, indigestion
• Muscle pain or cramps, leg pain, back pain
• Insomnia, headache, dizziness
• Weakness, tiredness, chest pain
• Increased potassium levels (which can cause an abnormal heart rhythm), decreased haemoglobin levels
• Changes in kidney function including kidney failure
• Too low sugar in the blood (hypoglycaemia)
• Low blood pressure, which may be associated with changes in posture (feeling light-headed or weak when you stand up, angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations
• Improper beating of the heart, whether irregular, too fast or too slow.

• The following side effects occur less frequently:
• Anaemia, red or brownish spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, reduction in white blood cells, clotting problems
• Loss of appetite, increased uric acid levels or frank gout, increased blood sugar levels, abnormal blood electrolyte levels
• Anxiety, nervousness, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, sleepiness, memory impairment
• Blurred vision, burning or stinging in the eyes, conjunctivitis, worsening eyesight, seeing things in yellow
• Ringing, buzzing, roaring or clicking in the ears, vertigo
• Inflammation of blood vessels, which is often associated with a skin rash or bruising
• Sore throat, breathlessness, bronchitis, pneumonia, water on the lungs (which causes difficulty breathing), nosebleed, runny nose, congestion

• Constipation, obstipation, wind, stomach upsets, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas
• Itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss
• Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
• Frequent urination including at night, abnormal kidney function including inflammation of the kidneys, urinary tract infection, sugar in the urine
• Swelling of the face, localised swelling (oedema), fever
• Pins and needles or similar sensations, pain in the extremities, trembling, migraine, fainting
• Increased urea and creatinine levels, increased liver enzymes

• The following side effects occur less frequently:
• Hepatitis (inflammation of the liver), abnormal liver function tests

• The following side effects occur with an unknown frequency:
• Thrombocytopenia (a low number of platelets in the blood)
• Pancreatitis (inflammation of the pancreas)
• Flu-like symptoms such as fever, chills, muscle aches, cough, congestion, runny nose, headaches and fatigue
• Liver problems
• Rhabdomyolysis (A breakdown of muscle tissue that causes muscle pain with dark (tea-coloured) urine)
• Decreased sex drive or impotence
• Orthostatic hypotension (A form of low blood pressure that happens when standing up from sitting or lying down)
• Hyponatraemia (A condition that occurs when the level of sodium in the blood is too low)
• Skin and lip cancer (Non-melanoma skin cancer)

- Keep out of the sight and reach of children.

- Do not store above 25°C. Store in the original package in order to protect from light and moisture.

- Do not use ANNIN CO after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.

- If your tablets become discoloured or show any other signs of deterioration, consult your doctor or pharmacist who will tell you what to do.

- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).