Endobloc t® kit

What ENDOBLOC T is used for?

• ENDOBLOC T is used to treat pulmonary arterial hypertension (PAH) in adults
• PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs

Warning and precautions

Talk to your doctor before taking this medicine, if you:
• are allergic to Ambrisentan, Tadalafil, soya, or any of the other ingredients of this medicine
• have scarring of the lungs, of unknown cause (idiopathic pulmonary fibrosis)
• have anaemia (a reduced number of red blood cells)
• have swelling in the hands, ankles or feet caused by fluid (peripheral oedema)
• suffer from lung disease where the veins in the lungs are blocked (pulmonary veno-occlusive disease)
• have heart problems such as angina (chest pain), heart failure, irregular heartbeats or have had a heart attack
• have low blood pressure or high blood pressure that is not controlled
• have had a stroke
• have kidney or liver problems
• have stomach ulcers
• have vision problem, including any damage to your optic nerve
• have ever had hearing problems such as ringing in the ears, dizziness or loss of hearing
• have a deformed penis shape or Peyronie’s disease
• have had an erection that lasted more than 4 hours
• have blood cell problems such as sickle cell anemia, multiple myeloma or leukemia

Pregnancy and breastfeeding

• Do not take ENDOBLOC T if you are pregnant or planning to become pregnant
• Do not breast-feed while you are taking this medicine

Children

ENDOBLOC T is not recommended for children and adolescents aged under 18 years as the safety and effectiveness is not established in this age group

Driving and Using Machines

• ENDOBLOC T may cause side effects, such as low blood pressure, dizziness, tiredness, that may affect your ability to drive or use machines
• Do not drive or use machines if you are feeling unwell

Interactions

Tell your doctor if you are taking, have recently taken or might take any other medicines such as:
• cyclosporine (a medicine used after transplant or to treat psoriasis)
• rifampicin (an antibiotic used to treat tuberculosis)
• other medicines used to treat pulmonary hypertension such as iloprost, epoprostenol, sildenafil
• nitrates or guanylate cyclase stimulators
• medicines used to treat hypertension
• protease inhibitors, used to treat HIV infection, such as ritonavir
• ketoconazole, itraconazole (medicines used to treat fungal infection)
• phenobarbital, phenytoin, carbamazepine used to treat fits
• other medicines for erectile dysfunction (impotence)

Directions for use

• Always take this medicine exactly as your doctor has told you to
• Swallow the medicine with a glass of water
• Do not split, crush or chew the medicine
If you take more ENDOBLOC T
• If you take more ENDOBLOC T, you may be more likely to have side effects, such as headache, flushing, dizziness, nausea (feeling sick), or low blood pressure that could cause light-headedness
• Contact your doctor or go to nearest hospital immediately
If you forget to take ENDOBLOC T
• If you forget a dose of ENDOBLOC T, just take the medicine as soon as you remember, then carry on as before
• Do not take two doses at the same time to make up for a forgotten dose
If you stop taking ENDOBLOC T
• Do not stop taking ENDOBLOC T without your doctor's advice

Side Effects

Serious

Like all medicines, this medicine can cause side effects, although not everybody gets them.
• allergic reactions marked by rash or itching and swelling (usually of the face, lips, tongue or throat) which may cause difficulty in breathing or swallowing
• swelling (oedema), especially of the ankles and feet
• heart failure (this is due to the heart not pumping out enough blood, causing shortness of breath, extreme tiredness and swelling in the ankles and legs)
• decreased eyesight in one or both eyes
• sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness
• erection that lasts more than 4 hours (with or without pain)

Common

Like all medicines, this medicine can cause side effects, although not everybody gets them.
• anaemia (reduced number of red blood cells) marked by tiredness, weakness, shortness of breath and generally feeling unwell
• hypotension (low blood pressure)
• flushing (redness of the skin)
• vomiting
• rash
• chest pain/discomfort
• blurry or other changes to vision
• fainting
• running nose
• constipation
• ringing in the ears (tinnitus)

Uncommon

Like all medicines, this medicine can cause side effects, although not everybody gets them.
• liver injury
• sudden hearing loss

Storage

• Store at room temperature (15-25ºC)
• Keep this medicine out of the reach of children
• Do not use this medicine after the expiry date