12.5 mg and 25 mg tablets
hydrochlorothiazide
1. What Hydrochlorothiazide Bluefish is and what it is used for
Hydrochlorothiazide is a diuretic and antihypertensive drug. The decrease in blood pressure is partly due to the diuretic effect but probably also to the fact that certain blood vessels ( arterioles ) dilate and thus reduce the resistance in the blood vessels.
Hydrochlorothiazide Bluefish is used to treat high blood pressure and fluid retention in the body ( edema ).
Hydrochlorothiazide contained in Hydrochlorothiazide Bluefish may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before you take Hydrochlorothiazide Bluefish
Do not take Hydrochlorothiazide Bluefish
- if you are allergic to hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other diuretics ( diuretics ) that belong to the group thiazides .
- if you are allergic to certain antibiotics ( sulfonamides ).
- if you have severe liver disease or kidney disease.
- if you have gout .
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Hydrochlorothiazide Bluefish
- if you have diabetes .
- if you have atherosclerosis in the brain or heart.
- if your potassium levels in the blood are low (with or without symptoms such as muscle weakness, muscle cramps and abnormal heartbeats).
- if your sodium levels in the blood are low (with or without symptoms such as fatigue, confusion, muscle cramps and seizures).
- if your blood calcium levels are high (with or without symptoms such as nausea, vomiting, constipation, abdominal pain, need to urinate frequently, thirst, muscle weakness or muscle cramps).
- if you have high levels of uric acid in your blood.
- if you experience impaired vision or sore eyes. This may be a symptom of increased pressure in the eye that may occur hours or weeks after starting treatment with Hydrochlorothiazide Bluefish. If left untreated, it can lead to visual impairment.
- 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 HydrochlorothiazideBluefish.
If you are taking Hydrochlorothiazide Bluefish for a long time, it is important that your diet contains enough potassium (consult your doctor).
Other drugs and Hydrochlorothiazide Bluefish
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to over-the-counter medicines.
Treatment with Hydrochlorothiazide Bluefish may be affected by other medicines. This is especially important for the following:
- Digitalis glycosides and sotalol (medicines that affect the heart rhythm).
- Drugs used to relieve pain, especially non-steroidal anti-inflammatory drugs ( NSAIDs ) (including Cox-2 selective NSAIDs ).
- Cholestipol and cholestyramine used to treat high blood cholesterol.
- Lithium, antidepressants and antipsychotics (medicines used to treat certain mental disorders).
- Antiepileptics e.g. carbamazepine (medicine used to treat epilepsy and seizures).
- Other antihypertensive drugs.
- Insulin and other medicines used to treat diabetes .
- Medicines used to treat ulcers and inflammation of the esophagus (carbenoxolone).
- Selective serotonin reuptake inhibitors ( SSRIs ) used to treat depression.
- Cortisone-like drugs, glucocorticoids .
- Medicines for the treatment of irregular heartbeat.
- Anticholinergics (medicines used to treat diseases such as stomach cramps, bladder spasm , asthma , motion sickness, Parkinson’s disease and to support anesthesia).
- Some medicines used to treat your infection , e.g. amphotericin, penicillin G.
- Alcohol, sleeping pills.
- Drugs that increase blood pressure (pressoramines, eg adrenaline , noradrenaline ).
- Muscle relaxants used during surgery.
Hydrochlorothiazide Bluefish with food and drink
Hydrochlorothiazide Bluefish can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or think you may be pregnant, ask your doctor for advice. Your doctor will usually suggest that you take another medicine instead of Hydrochlorothiazide Bluefish as Hydrochlorothiazide Bluefish is not recommended during pregnancy. This is because Hydrochlorothiazide Bluefish passes into the fetus and can harm the fetus and the newborn baby if used during the last 6 months of pregnancy.
Breast-feeding
Tell your doctor if you are breastfeeding or planning to breastfeed. Hydrochlorothiazide Bluefish is not recommended for breastfeeding mothers.
Always consult a doctor or pharmacist before taking any medicine.
Driving and using machines
Hydrochlorothiazide Bluefish 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 sharpened attention. 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.
Hydrochlorothiazide Bluefish contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Hydrochlorothiazide Bluefish
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual daily dose for adults is:
Hypertension:
The recommended daily dose is 12.5 mg to 50 mg per day.
Edema:
The recommended daily dose is 25 mg to 50 mg, in severe cases 75 mg to 100 mg per day.
The recommended dose should be taken in the morning (as a single dose) or divided into two doses, morning and evening, depending on what the doctor considers best for you. The tablets should be taken 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 Hydrochlorothiazide Bluefish than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Symptoms of overdose are disturbances in the fluid and salt balance, thirst, dehydration, and disturbances in the acid-base balance of the blood.
If you forget to take Hydrochlorothiazide Bluefish
If you forget to take your medicine, take it as soon as you remember. Then continue taking your next dose at the usual time. If it is already time for 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, this medicine can cause side effects, although not everybody gets them.
Stop taking Hydrochlorothiazide Bluefish and consult a doctor or see your nearest hospital if you experience any of the following serious side effects:
- Agranulocytosis – Hydrochlorothiazide Bluefish can in very rare cases adversely affect the white blood cells of the immune system. If you develop an infection with symptoms such as fever in combination with a severe worsening of the general condition or fever with symptoms of a local infection such as sore throat / mouth or difficulty urinating, you should contact a doctor immediately so that blood tests can be taken to rule out deficiency. on white blood cells ( agranulocytosis ). It is important that you inform the healthcare staff about your medication in connection with this.
- Toxic epidermal necrolysis – In rare cases, Hydrochlorothiazide Bluefish can cause severe skin damage (skin peeling of the epidermis and superficial mucous membranes). If these side effects are not treated immediately, they can be life-threatening.
- Acute narrow-angle glaucoma – In very rare cases, severe pain in the eyes, a red eye, reduced or foggy vision and that you see rings around light sources along with nausea and vomiting may occur. This can be a symptom of acute narrow-angle glaucoma that can occur when the pressure in the fluid in the eye rises rapidly. Immediate treatment is required to reduce symptoms and to avoid permanent loss of vision (severe visual impairment).
Other side effects include:
Common (may affect up to 1 in 10 people):
- Weakness, dizziness, tiredness, headache
- Potassium deficiency, elevated levels of uric acid in the blood (sometimes with gout problems), high blood sugar and elevated levels of blood fats (at high doses ).
Uncommon (may affect up to 1 in 100 people):
- Fainting due to low blood pressure when standing up
- Irregular heartbeat
- Anorexia , nausea, vomiting, colic , diarrhea, constipation
- Skin rash, hives , increased sensitivity to sunlight
- Disorders of blood salt balance and acid-base balance.
Rare (may affect up to 1 in 1,000 people):
- Severe hypersensitivity reaction
- Peeling of the skin
- Fever
- Impotence
- Anemia ( anemia ), lack of white blood cells ( leukopenia , agranulocytosis ), a shortage of blood platelets ( thrombocytopenia )
- Tingling, sleep disturbances
- Depression
- Inflammation of the blood vessels ( vasculitis )
- Inflammation of the pancreas, effect on liver function
- Respiratory symptoms
- Disorders of kidney function
- Dimsyn.
Has been reported (occurs in an unknown number of users):
- Renal failure , renal impairment
- Anemia due to bone marrow depression (deterioration of bone marrow function)
- Rash, muscle cramps
- Acute glaucoma ( acute increase in pressure in the eye)
- Skin and lip cancer (Non- melanoma skin cancer)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Hydrochlorothiazide Bluefish
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after “EXP”. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Sensitive to light.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is hydrochlorothiazide.
12.5 mg: Each tablet contains 12.5 mg of hydrochlorothiazide
25 mg: Each tablet contains 25 mg of hydrochlorothiazide
Other ingredients are:
Lactose monohydrate, corn starch, talc, colloidal anhydrous silica, and magnesium stearate
What the medicine looks like and contents of the pack
Hydrochlorothiazide Bluefish 12.5 mg tablets are white, round, biconvex tablets with a diameter of 5.8 to 6.2 mm and a thickness of 3.0 to 3.6 mm.
Hydrochlorothiazide Bluefish 25 mg tablets are white, round, flat tablets with a diameter of 7.8 to 8.2 mm and a thickness of 2.7 to 3.4 mm with a break notch on one side.
The tablet can be divided into two equal doses.
Pack sizes:
12.5 mg
PVC / Aluminum blisters: 100 and 250 tablets
25 mg
PVC / Aluminum blisters: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
PO Box 49013
100 28 Stockholm
Sweden
Manufacturer
Zaklady Farmaceutyczne Polpharma SA
(Pharmaceutical Works Polpharma SA)
19 Pelplińska Street, 83-200 Starogard Gdański
Poland
This medicinal product is authorized under the European Economic Area under the names:
| Portugal | Hydrochlorothiazide Bluefish 12.5 mg & 25 mg compressed |
| Sweden | Hydrochlorothiazide Bluefish |