TOLUCOMBI 80 mg/25 mg Tablet Ref.[28078] Active ingredients: Hydrochlorothiazide Telmisartan

Posology

Tolucombi should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone. Individual dose titration with each of the two components is recommended before changing to the fixed dose combination. When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.

• Tolucombi 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Tolucombi 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.

Tolucombi is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg.

Renal impairment

Periodic monitoring of renal function is advised (see section 4.4).

Hepatic impairment

In patients with mild to moderate hepatic impairment the posology should not exceed Tolucombi 40 mg/12.5 mg once daily. Tolucombi is not indicated in patients with severe hepatic impairment.

Thiazides should be used with caution in patients with impaired hepatic function (see section 4.4).

Elderly

No dose adjustment is necessary.

Paediatric population

The safety and efficacy of Tolucombi in children and adolescents aged below 18 have not been established. No data are available.

Method of administration

Tolucombi tablets are for once-daily oral administration and should be taken with liquid, with or without food.

There is limited information available for telmisartan with regard to overdose in humans. The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.

Symptoms

The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported. Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis. The most common signs and symptoms of overdose are nausea and somnolence. Hypokalaemia may result in muscle spasms and/or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.

Treatment

Telmisartan is not removed by haemodialysis. The patient should be closely monitored, and the treatment should be symptomatic and supportive. Management depends on the time since ingestion and the severity of the symptoms. Suggested measures include induction of emesis and/or gastric lavage. Activated charcoal may be useful in the treatment of overdose. Serum electrolytes and creatinine should be monitored frequently. If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.

Blisters (OPA/Al/PVC foil//Al foil): 3 years.

Blisters (OPA/Al/PE foil with desiccant//Al foil): 2 years.

This medicinal product does not require any special temperature storage conditions.

Store in the original package in order to protect from light.

Blisters (OPA/Al/PVC foil//Al foil): 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 84 × 1, 90 × 1, 98 × 1 and 100 × 1 tablet in a box.

Blisters (OPA/Al/PE foil with desiccant//Al foil): 14 × 1 and 98 × 1 tablet in a box. Not all pack sizes may be marketed.

No special requirements.