25 mg tablet
hydrochlorothiazide
1. WHAT ESIDREX IS AND WHAT IT IS USED FOR
Esidrex is a diuretic and antihypertensive drug. The decrease in blood pressure is partly due to the diuretic effect but probably also due to the dilation of certain blood vessels ( arterioles ).
Esidrex is used for high blood pressure, fluid retention ( edema ), and Ménière’s disease (an inner ear disease).
The hydrochlorothiazide contained in Esidrex may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
BEFORE YOU TAKE ESIDREX
Do not take Esidrex
if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Esidrex.
– if you are allergic (hypersensitive) to certain other diuretics ( diuretics ).
– if you have severe liver disease.
– if you have severe kidney disease with low urine production.
– if you have gout.
If any of the above applies to you, do not take Esidrex and talk to your doctor.
Take special care with Esidrex
– if you have diabetes (diabetes).
– if you have atherosclerosis in the heart or brain.
– if you are pregnant: Pregnant women should not use Esidrex during the last 3 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Esidrex, see Pregnancy and breast-feeding).
– if you have low potassium levels in your blood (with or without symptoms such as muscle weakness, muscle cramps, abnormal heart rhythm).
– if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures).
– if you have high calcium levels in your blood (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, frequent urination, thirst, muscle weakness, or muscle twitching).
– if you have high levels of uric acid in your blood.
– if you experience a decrease in vision or have eye pain. These may be symptoms of increased pressure in the eye that may occur hours or weeks after starting Esidrex. This can lead to visual impairment if left untreated.
– if you have asthma or allergic symptoms.
– if you have had skin cancer or if you get an unforeseen skin change during treatment. Treatment with hydrochlorothiazide, especially long-term use with 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 Esidrex.
If any of the above applies to you, do not take Esidrex and talk to your doctor.
For long-term treatment with Esidrex, the diet must contain enough potassium (consult a doctor).
Esidrex contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Esidrex.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The treatment effect may be affected if this medicine is taken at the same time as certain other medicines. This primarily applies to the following drugs:
- digitalis glycosides and sotalol (drugs that affect the heart rhythm).
- drugs used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs ( NSAIDs ) (including Cox 2-selective agents).
- colestipol, cholestyramine, or other resins (medicines for high blood fats).
- lithium, antidepressants, antipsychotics (drugs used in certain mental disorders).
- antiepileptics such as carbamazepine (medicines used to treat epilepsy and seizures).
- other antihypertensive drugs.
- insulin and other medicines for diabetes.
- drugs used for ulcers or inflammation of the esophagus (carbenoxolone).
- cortisone-like drugs, steroids.
- drugs for the treatment of irregular heartbeat.
- anticholinergic drugs (drugs used to treat various diseases such as stomach cramps, bladder spasm, asthma, motion sickness, muscle cramps, Parkinson’s disease, and as an aid to anesthesia).
- Some medicines used to treat infection include amphotericin, penicillin G.
- alcohol, sleeping pills.
- drugs that increase blood pressure (pressor amines such as adrenaline, norepinephrine ).
- muscle relaxants used during surgery.
The treating physician, therefore, needs to be aware of such concomitant medication.
Taking Esidrex with food and drink
Esidrex can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
Contact your doctor if you are pregnant or think you may be pregnant. Your doctor will usually suggest you take another medicine instead of Esidrex as Esidrex is not recommended during pregnancy. This is because Esidrex passes into the fetus and can cause harm to the fetus and the newborn baby if used during the last 6 months of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or planning to start breast-feeding. Esidrex is not recommended during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Esidrex has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. HOW TO TAKE ESIDREX
Always take Esidrex exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual daily dose for adults is
– 1 / 2-1 tablet (high blood pressure ),
– 1-2 tablets ( edema ),
– 2-4 tablets ( Ménières disease ).
The recommended dose of Esidrex should be taken in the morning (as a single dose) or divided into two doses, morning and evening if your doctor thinks it is best for you. Swallow the tablets with a glass of water.
The increased urine excretion begins about 2 hours after ingestion, is greatest after about 4 hours, and lasts about 12 hours.
If you take more Esidrex than you should
If you have received too much medicine, always contact a doctor, hospital, or the Poison Information Center
If you forget to take Esidrex
If you forget to take your medicine, take it as soon as you remember. Then take your next dose at the usual time. However, if it is soon time to take your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Esidrex can cause side effects, although not everybody gets them.
During treatment with Esidrex, some patients may experience side effects ( side effects ).
Adverse reactions are classified into common (affects more than 1 in 100 patients), uncommon (affects less than 1 in 100 patients), and rare (affects less than 1 in 1,000 patients), no known frequency (frequency cannot be calculated from available data).
Usual
Weakness, dizziness, fatigue, headache, potassium deficiency, elevated levels of uric acid in the blood (possibly with gout problems), elevated blood sugar levels, and elevated levels of blood fats (at high doses ).
Less common
Dizziness when getting up quickly, irregular heartbeat, anorexia, nausea, vomiting, colic, diarrhea, constipation, skin rash, hives, increased sensitivity to sunlight, salt balance disorders, and acid-base balance.
Rare
Strong hypersensitivity reaction, local peeling of the skin, fever, impotence, anemia ( anemia ), lack of white blood cells ( leukopenia, agranulocytosis ), a shortage of blood platelets ( thrombocytopenia ), sensory disturbances, sleep disturbances, depression, blood vessel inflammation ( vasculitis ), inflammation of the pancreas, the effect on the liver function, respiratory symptoms, effects on kidney function and blurred vision.
No known frequency
Acute renal failure, renal impairment, anemia due to bone marrow depression, skin rash, fever, muscle twitching, weakness, acute glaucoma, skin, and lip cancer (Non- melanoma skin cancer).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ESIDREX
Keep out of sight and reach of children.
Close the jar tightly. Moisture sensitive.
Store in the original package. Sensitive to light.
Do not use this medicine after the expiry date which is stated on the carton after “Ed. That ”. The expiration date is the last day of the specified month.
Do not use any damaged or pre-opened Esidrex packs.
6. FURTHER INFORMATION
Content declaration
– The active substance in Esidrex is hydrochlorothiazide. One tablet contains 25 mg of hydrochlorothiazide .
– The other ingredients are lactose monohydrate, magnesium stearate, colloidal anhydrous silica, talc, and wheat starch.
What the medicine looks like and the contents of the pack
Esidrex 25 mg tablets are white with a scoreline on one side.
The tablets are supplied in a plastic jar of polyethylene with 100 pcs.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Juvisé Pharmaceuticals Laboratories
149 boulevard Bataille de Stalingrad
69100 Villeurbanne
France
Manufacturer
Cenexi
52 Rue Marcel and Jacques Gaucher
94120 Fontenay-sous-Bois
France
For further information on this medicine, please contact the Marketing Authorization Holder.