Tolucombi 80 mg/12.5 mg Used For, Side Effects

Tolucombi combines two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both of these substances help control high blood pressure.

Telmisartan belongs to a group of medicines called angiotensin -II inhibitors. Angiotensin II is a body substance that causes your blood vessels to become narrower, which in turn causes your blood pressure to rise. Telmisartan blocks this effect of angiotensin II, leading to dilating blood vessels and lowering blood pressure.
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics which cause increased urine output and lowers your blood pressure.

Untreated high blood pressure can cause vascular damage in multiple organs, sometimes leading to heart attack, heart failure, kidney failure, stroke, or blindness. Most of the time, high blood pressure causes no symptoms before the damage occurs. It is, therefore, important to regularly measure blood pressure to confirm that it is normal.

Tolucombi (40 mg/12.5 mg, 80 mg/12.5 mg) treats high blood pressure ( essential hypertension ) in adults whose blood pressure is not adequately controlled when telmisartan is used alone.

Tolucombi (80 mg/25 mg) treats high blood pressure ( essential hypertension ) in adults whose blood pressure is not adequately controlled by Tolucombi 80 mg/12.5 mg or in patients previously stabilized with telmisartan and hydrochlorothiazide separately.

What You Need To Know Before Using Tolucombi:

Do Not Use Tolucombi

If you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
If you are allergic to hydrochlorothiazide or any sulfonamide derivative.
Pregnant women should not use Tolucombi during the last 6 months of pregnancy. (Even earlier in pregnancy, avoid Tolucombi; see Pregnancy and breastfeeding).
If you have severe liver problems such as cholestasis or biliary obstruction (problems with the outflow of bile from the liver and gallbladder) or any other severe liver disease.
If you have severe kidney disease.
If your doctor determines that your blood has low potassium or high calcium levels that do not improve with treatment.
If you have diabetes or impaired kidney function and are being treated with a medicine containing aliskiren.

Tell your doctor or pharmacist before taking Tolucombi if any of the above apply.

Warnings And Precautions:

Talk to your doctor before taking Tolucombi if you have or have had any of the following conditions or diseases:
Low blood pressure ( hypotension ) often occurs if you are dehydrated (severe loss of body fluid) or if you have a salt deficiency due to diuretic treatment (water-reducing treatment), low-salt diet, diarrhea, vomiting, or hemodialysis.
Kidney disease or if you have had a kidney transplant.
Renal artery stenosis (narrowing of blood vessels leading to one or both kidneys).
Liver disease.
Heart problems.
Diabetes.
Gout.
Increased aldosterone levels (water and salt accumulation in the body and imbalance of various minerals in the blood).
Systemic lupus erythematosus (also called “lupus” or “SLE”) is disease in which the body’s immune system attacks the body.
The active substance hydrochlorothiazide can cause an unusual reaction that causes impaired vision and eye pain. These may be symptoms of fluid accumulation in the eye (between the choroid and sclera) or increased pressure in your eye and may occur within hours to weeks of taking Tolucombi. It can lead to permanent vision loss if the condition is not treated.
If you have had skin cancer or get an unexpected skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Tolucombi.
If you have previously had breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you experience severe shortness of breath or breathing problems after taking Tolucombi, seek medical attention immediately.

Talk to your doctor before taking Tolucombi if you are taking:

Digoxin
Any of the following medicines used to treat high blood pressure:
- An ACE inhibitor (eg enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
- The aliskiren.

If you think you are pregnant or become pregnant during treatment, contact your doctor. Tolucombi is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it can then cause birth defects, see Pregnancy and breastfeeding.

Treatment with hydrochlorothiazide can cause disturbances in the electrolyte balance in your body. Typical symptoms of disturbed fluid or electrolyte balance are:

Dry mouth
Weakness
Lack of energy
Sleepiness
Restlessness
Muscle pain or cramps
Nausea (feeling sick)
Vomiting
Muscle fatigue
Abnormally fast pulse (faster than 100 beats per minute).

If you experience any of these symptoms, tell your doctor. You should also tell your doctor if you experience that your skin is more sensitive to sunlight, with symptoms such as:

Sunburn such as:
- Redness
- Itching
- Swelling
- Blisters

That develop faster than normal. If you are going to have surgery or be sedated, tell your doctor that you are using Tolucombi tablets. Tolucombi may be less effective in lowering blood pressure et in colored patients.

Your doctor may need to check kidney function, blood pressure, and the number of electrolytes (e.g. potassium ) in the blood regularly. See also the information under the heading “Do not use Tolucombi”.

Children And Young People:

Use of Tolucombi in children and adolescents up to 18 years of age is not recommended.

Other Medicines And Tolucombi:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines. Your doctor may need to change the dose of the other medicines or take other measures. Sometimes, you may need to stop taking some of the medicines. This applies in particular to the medicines listed below if they are taken at the same time as Tolucombi:

Lithium-containing medicines treat certain types of depression.
Medicines associated with low levels of potassium in the blood ( hypokalemia ), such as diuretics (water-reducing drugs), laxatives (eg castor oil), corticosteroids (eg prednisone), ACTH (a hormone ), amphotericin (an antifungal agent), carbenoxolone (used in the treatment of mouth ulcers), penicillin -G- sodium (an antibiotic ), salicylic acid and derivatives.
Medicines that can increase blood potassium levels include potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, ciclosporin (a medicine that suppresses the immune system), and other medicines such as heparin sodium (an anticoagulant ).
Medicines whose effect is affected by changes in the potassium value of the blood, such as heart medicines (eg digoxin ) or medicines that control your heart rhythm (eg quinidine, disopyramide, amiodarone, sotalol), medicines used in mental illnesses (eg thioridazine, chlorpromazine, levomepromazine) and other medicines such as certain antibiotics (sparfloxacin, pentamidine) or certain allergy medicines (terfenadine).
Diabetes medicines ( insulin or tablets such as metformin ).
Medicines are used to lower the level of blood fats (cholestyramine and colestipol).
Blood pressure-raising drugs such as norepinephrine.
Muscle relaxants such as tubocurarine.
Calcium or vitamin D supplements.
Anticholinergic drugs (drugs for various medical conditions, e.g. spasms in the gastrointestinal tract, muscle spasms in the bladder, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as support during anesthesia) such as atropine and biperiden.
Amantadine (medicine to treat Parkinson’s disease and treat or prevent certain viral diseases).
Other drugs to treat high blood pressure are corticosteroids, painkillers (NSAIDs, anti-inflammatory drugs), and drugs to treat cancer, gout, or arthritis.
If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Tolucombi” and “Warnings and precautions”).
Digoxin

Tolucombi can increase the blood pressure-lowering effect of other medicines or medicines that can lower blood pressure (eg baclofen, amifostine). In addition, low blood pressure can be worsened by alcohol, barbiturates, narcotics, and antidepressants.

You may notice it as dizziness when you stand up. You should consult your doctor if you need to change the dose of any of your other medicines when taking Tolucombi. The effect of Tolucombi can be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, eg acetylsalicylic acid or ibuprofen ).

Tolucombi With Food, Drink, And Alcohol:

You can take Tolucombi with or without food. Avoid drinking alcohol until you have spoken to your doctor. Alcohol can cause your blood pressure to drop further and increase your risk of dizziness or fainting.

Pregnancy, Breastfeeding, And Fertility:

Pregnancy

If you think you are pregnant or become pregnant during treatment, contact your doctor. Your doctor will usually suggest that you stop taking Tolucombi before pregnancy or as soon as you know you are pregnant and instead recommend another medicine. Tolucombi should not be used during pregnancy or during the last 6 months of pregnancy as it may cause birth defects.

Breast-feeding

Tell your doctor if you are breastfeeding or intend to start breastfeeding. Tolucombi is not recommended during breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed your baby.

Driving Ability And Use Of Machinery:

Some people feel dizzy or tired after taking Tolucombi. If you feel dizzy or tired, do not drive or use machines.

Tolucombi Contains Lactose, Sorbitol And Sodium:

If you are intolerant to certain sugars, you should consult your doctor before taking this medication.

Tolucombi 40 mg/12.5 mg contains 147.04 mg sorbitol per tablet, corresponding to 5 mg/kg/day, if the body weight is 29.8 kg.
Tolucombi 80 mg/12.5 mg and Tolucombi 80 mg/25 mg contain 294.08 mg sorbitol per tablet, corresponding to 5 mg/kg/day, if the body weight is 58.8 kg.
Patients weighing 58.8 kg or less must consider sorbitol as a source of fructose. If you (or your child) have an intolerance to some sugars, or if you (or your child) have been diagnosed with Hereditary Fructose Intolerance (HFI), a rare, inherited condition that prevents the breakdown of fructose, consult a doctor before using this drug.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost “sodium-free”.

How To Use Tolucombi?

Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The recommended dose of Tolucombi is one tablet per day.
Try to take the tablet at the same time each day. You can take Tolucombi with or without food.
The tablets should be swallowed with a little water or another non-alcoholic drink.
It is important to continue taking Tolucombi daily until your doctor tells you otherwise. If your liver is not working properly, the normal dose should not exceed 40 mg/12.5 mg once daily.

If You Have Used Too Much Tolucombi:

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and heart palpitations. Symptoms such as:

Low heart rate
Dizziness
Vomiting
Impaired kidney function, including kidney failure, have also been reported.

Due to the content of hydrochlorothiazide, markedly low blood pressure and low potassium levels in the blood may occur, which may cause:

Nausea
Sleepiness
Muscle cramps
Irregular heartbeats in connection with the simultaneous use of digitalis or certain antiarrhythmic drugs.

Contact your doctor, pharmacist, or nearest emergency department immediately.

If You Forget To Use Tolucombi:

Do not worry if you forget to take a dose. Take dose one as soon as you remember and then continue as before. If you forget the medicine one day, take the usual dose the next day.

Do not take a double dose to make up for missed doses. Contact your doctor or pharmacist if you have further questions about this medicine.

Possible Tolucombi Side Effects

This medicine can cause side effects like all medicines, although not everybody gets them.

Some side effects can be serious and require immediate medical treatment.

Contact your doctor immediately if you experience any of the following symptoms:

Sepsis* (which is often called “blood poisoning”) is a severe infection with inflammatory reactions throughout the body, rapid swelling of the skin and mucous membranes ( angioedema ), blisters, and peeling of the outermost layer of the skin ( toxic epidermal necrolysis );

These side effects are rare (may occur in up to 1 in 1,000 users) or have an unknown frequency ( toxic epidermal necrolysis ) but are extremely serious. Patients should stop taking medicine and see a doctor immediately.

The conditions can be fatal if left untreated. An increased incidence of sepsis has been observed with telmisartan alone but cannot be excluded for Tolucombi.

Possible side effects of Tolucombi:

Common tolucombi side effects ( may affect up to 1 in 10 users):

Dizziness

Uncommon side effects ( may affect up to 1 in 100 users):

Decreased potassium levels
Restlessness
Fainting ( syncope )
Experiencing numbness
Tingling (paraesthesia)
Dizziness ( vertigo )
Fast heart rate ( tachycardia )
Heart rhythm disturbances
Low blood pressure
Sudden drop in blood pressure when standing up
Shortness of breath ( dyspnoea )
Diarrhea
Dry mouth
Whether tension
Back pain
Muscle spasms
Muscle pain
Erectile dysfunction (inability to get or maintain an erection )
Chest pain
The increased uric acid level in the blood

Rare side effects ( may affect up to 1 in 1,000 users):

Inflammation of the lungs ( bronchitis )
Activation or worsening of systemic lupus erythematosus (a disease in which the body’s immune system attacks its own body, causing joint pain, skin rash, and fever)
Sore throat
Inflamed sinuses
Depression
Insomnia
Impaired vision
Difficulty breathing
Stomach pain
Constipation
Belching ( dyspepsia )
Nausea (vomiting)
Inflammation of the stomach ( gastritis )
Abnormal liver function (Japanese patients are more likely to have this side effect)
Reddening of the skin ( erythema )
Allergic reactions such as itching or rash;
- Increased sweating
Hives ( urticaria )
Joint pain ( arthralgia ) and pain in the arms and legs
Muscle cramps
Flu-like illness
Pain
Low levels of sodium in the blood
Increased levels of creatinine
Liver enzymes or creatine phosphokinase in the blood

Side effects reported for one of the individual components may be a possible side effect with Tolucombi, even if they were not observed in clinical studies with this drug.

Telmisartan

In patients using only telmisartan, the following side effects have also been reported:

Uncommon side effects ( may affect up to 1 in 100 users):

Upper respiratory infection (for example, sore throat)
Inflamed sinuses (The common cold)
Urinary tract infections
Lack red blood cells ( anemia )
High potassium levels
Slow heart rate ( bradycardia )
Impaired kidney function, including acute kidney failure
Weakness,
Cough

Rare side effects ( may affect up to 1 in 1,000 users):

Low platelet count ( thrombocytopenia )
Increase in certain white blood cells ( eosinophilia )
Severe allergic reactions (for example, hypersensitivity, anaphylactic reaction, drug rash)
Low blood sugar (in patients with diabetes )
Upset stomach
Eczema (a skin disease)
Osteoarthritis
Tendonitis
Decreased hemoglobin levels (a protein in the blood), tiredness

Very rare side effects ( may affect up to 1 in 10,000 users):

Progressive scarring of lung tissue (interstitial lung disease)**

* These side effects may be coincidental or related to a currently unknown mechanism.

** Cases of progressive scarring of lung tissue have been reported with treatment with telmisartan. However, it is not known whether telmisartan is the cause.

Hydrochlorothiazide

In patients using only hydrochlorothiazide, the following side effects have also been reported:

Common side effects (may affect up to 1 in 10 users):

Nausea
Low levels of magnesium in the blood

Rare side effects (may affect up to 1 in 1,000 users):

Decreased number of blood platelets increases the risk of bleeding or bruising (small purple-red dots in the skin or other tissue caused by bleeding)
High levels of calcium in the blood
Headache

Very rare side effects (may affect up to 1 in 10,000 users):

Increased pH (disturbed acid-base balance) due to low chloride levels in the blood, acute respiratory distress syndrome signs of this are:
- Severe shortness of breath
- Fever
- Weakness
- Confusion

Side effects with no known frequency (frequency cannot be calculated from available data):

Salivary gland inflammation
Skin and lip cancer (Non- melanoma skin cancer)
Decreased number (or even lack of) blood cells, including low red and white blood cell counts
Severe allergic reactions eg:
- Hypersensitivity
- Anaphylactic reactions
Decreased appetite or loss of appetite
Restlessness
Dizziness
Blurred vision or yellow-colored field of vision
Impaired vision and eye pain (possible sign of fluid accumulation in the eye (between the choroid and the sclera) or acute narrow-angle glaucoma )
Inflammation of blood vessels ( necrotizing vasculitis )
Inflamed pancreas
Upset stomach
Yellowed skin or yellowed eyes (jaundice)
Lupus-like syndrome (a condition similar to a disease called systemic lupus erythematosus in which the body’s immune system attacks its own body)
Skin diseases such as:
- Inflamed blood vessels in the skin
- Increased sensitivity to sunlight
- Rash
- Redness of the skin
- Blisters on the lips, eyes or mouth
- Scaly skin
Fever (possible signs of erythema multiforme)
Weakness, inflammation of the kidneys or impaired kidney function
Glucose in the urine (glycosuria)
Fever
Impaired salt balance (electrolyte balance)
High blood cholesterol levels
Decreased blood volume
Increased blood glucose levels
Difficulty controlling blood/urine glucose levels in patients with diabetes or fat in the blood

How Should Tolucombi Be Stored?

Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the carton, and blister after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original packaging to protect against
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents Of The Packaging And Other Information

Contents Declaration

The active ingredients are telmisartan and hydrochlorothiazide.
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Other ingredients are hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, meglumine, povidone (K30), red iron oxide (E172) – only in the 40 mg/12.5 mg and 80 mg/12.5 mg tablets, anhydrous colloidal silicon, sodium hydroxide (E524), sodium stearyl fumarate, sorbitol (E420) and yellow iron oxide (E172) – only in the 80 mg/25 mg tablets. See section 2, “Tolucombi contains lactose, sorbitol, and sodium”.

Appearance And Package Sizes Of The Medicine:

40 mg/12.5 mg tablets: white to off-white or pinkish white on one side and pink marbled on the other of the bi-layer biconvex, oval tablet, tablet dimensions 15 mm x 7 mm.
80 mg/12.5 mg tablets: white to off-white or pinkish white on one side and pink marble on the other of the bi-layered biconvex, oval tablet, tablet dimensions 18 mm x 9 mm.
80 mg/25 mg tablets: white to yellowish white on one side and yellow marbled on the other of the bilayer biconvex, oval tablet, tablet dimensions 18 mm x 9 mm.
Blister (OPA/Al/PVC foil//Al foil): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 and 100 x 1 tablet in a carton.
Blister (OPA/Al/PE foil with desiccant//Al foil): 14 x 1 and 98 x 1 tablets in a carton.
Not all pack sizes may be marketed

Marketing Authorization Holder And Manufacturer:

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer