Alu-Cap 475mg capsules

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
07-06-2018
Shusha Tabia za bidhaa (SPC)
07-06-2018

Viambatanisho vya kazi:

Aluminium hydroxide

Inapatikana kutoka:

Meda Pharmaceuticals Ltd

ATC kanuni:

A02AB01

INN (Jina la Kimataifa):

Aluminium hydroxide

Kipimo:

475mg

Dawa fomu:

Oral capsule

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 01010100; GTIN: 5000485088505

Taarifa za kipeperushi

                                Read this entire leaflet carefully before you start taking this
medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms
are the same as yours.
In this leaflet:
1. What Alu-cap is for
3. How to take Alu-cap
5. How to store Alu-cap
2. Before you use Alu-cap
4. Possible side effects
6. Further information
1. What Alu-cap is for
Alu-cap belongs to a group of medicines called antacids.
Alu-cap can be used for the relief of indigestion. It neutralises the
acid in the stomach and helps to protect the
stomach lining from acid irritation.
Alu-cap may also be used to reduce the amount of phosphate ions
absorbed by the body from the diet.
This helps to reduce the levels of phosphate in the blood which is
important in patients with certain kidney diseases.
2. Before you use Alu-cap
Do not take Alu-cap:
• if you are allergic to aluminium hydroxide
• if you are allergic to other ingredients of Alu-cap (listed in
section 6)
• if you have low levels of phosphate in your body
(hypophosphataemia)
• if you have a blood disorder called porphyria.
This medicine should not be used as an antacid in children under 12
years of age.
Check with your doctor before taking Alu-cap:
• if you have kidney failure or are on dialysis.
Tell your doctor if you are taking any of the following medicines:
Alu-cap may affect how much of these medicines get into your body.
• if you are taking antibiotics, e.g. tetracycline, ampicillin,
co-trimoxaxole
• if you are taking iron supplements, e.g. ferrous sulphate
• if you are taking heart medications, e.g. digoxin, quinidine
• if you are taking pain relief medicines, e.g. indometacin,
phenybutazone
• if you are taking anti-arthritis medicines, e.g. naproxen
• if you are taking vitamins
• Any other medicine, including medicines obtained without a
prescription.
Pregnancy and breast-feeding
If yo
                                
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Tabia za bidhaa

                                OBJECT 1
ALU-CAP CAPSULES
Summary of Product Characteristics Updated 11-Mar-2014 | Meda
Pharmaceuticals
1. Name of the medicinal product
Alu-Cap Capsules
2. Qualitative and quantitative composition
Each capsule contains 475 mg Dried Aluminium Hydroxide Gel Ph Eur as a
white powder.
3. Pharmaceutical form
Hard gelatin capsules
4. Clinical particulars
4.1 Therapeutic indications
Alu-Cap is recommended for use as a phosphate binding agent in the
management of renal failure. It may
also be used as an antacid.
4.2 Posology and method of administration
FOR PHOSPHATE BINDING
ADULTS AND CHILDREN: The dosage must be selected in accordance with
individual patient
requirements, and may range from 4 to 20 capsules of Alu-Cap daily
(approximately 2 to 10 g dried
aluminium hydroxide gel), taken with meals.
AS AN ANTACID
ADULTS: One Alu-Cap four times daily and on retiring.
CHILDREN: Alu-Cap is not suitable for antacid therapy in children.
ELDERLY: No special dosage recommendations are made for elderly
patients.
4.3 Contraindications
Alu-Cap is contra-indicated in patients with hypophosphataemia and
acute porphyria.
4.4 Special warnings and precautions for use
Phosphate depletion: Aluminium salts may cause phosphate depletion,
which is generally negligible. On
prolonged treatment with large doses hypophosphataemia may occur,
especially in patients with restricted
phosphate intake. This syndrome is characterised by anorexia, malaise
and muscle weakness. If left
unchecked this condition may give rise to osteomalacia, osteoporosis
and urinary calculi. Serum
phosphate levels should be monitored regularly (bi-monthly) in
patients on maintenance haemodialysis
who are receiving chronic aluminium hydroxide therapy.
Renal failure: In patients with chronic renal failure,
hyperaluminaemia may occur. Aluminium
accumulates in the bone, lungs and nerve tissue. Aluminium
accumulation in the CNS may be the cause
of dialysis dementia which sometimes occurs in chronic renal failure
patients receiving long term
aluminium therapy for hyperphosphat
                                
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