Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Phosex 1000mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Calcium acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR
Phosex Tablets belong to a group of medicines called phosphate binders and are only available on prescription from your doctor. The tablets are most commonly used to remove phosphate from your body when it has too much. They must be used together with advice on your diet and in addition to your other kidney treatment.
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What you need to know before you take it
E PHOSEX TABLETS
Do not take Phosex if: • You have been given Phosex (calcium acetate) before and had an allergic reaction. (See Section 4 for symptoms.) • You have had an allergic reaction to any of the other ingredients. (See Section 6 for a list of these.) • You suffer from high levels of calcium in your blood (hypercalcaemia). Warnings and precautions: Talk to your doctor or pharmacist before taking Phosex Tablets. Before you start taking these tablets, tell your doctor if: • you are pregnant, or may become pregnant, or you are breast feeding. • you are taking:
- any antibiotics.
- calcium antagonists such as verapamil (for your heart or blood pressure).
- digitalis glycosides (for your heart).
- Any antacids containing calcium carbonate or other calcium salts.
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• • •
you know you suffer from high blood levels of calcium (detectable through medical tests). Your doctor will inform you of symptoms of this condition. You are taking or going to take products containing vitamin D at the same time as Phosex. Check with your doctor if you are not sure.
Please note: • The levels of phosphate and calcium in your blood will be checked regularly. • As a result of your kidney disease, you may suffer from conditions called ectopic or vascular calcification, or from adynamic bone disease. Your doctor will carry out regular tests for signs of these. Other medicines and Phosex Tablets • Tell your doctor if you are taking, have recently taken or might take any other medicines, including ones you have bought without a prescription. • If you are taking Phosex Tablets with antibiotics, please see the arrangements described in Section 3, under Dosage. • If you are taking vitamin D, your doctor may need to adjust your dosage. • Your doctor may take extra precautions with you if you are taking digitalis, glycosides, verapamil or gallopamil. • Before taking any antacids or indigestion medicines obtained without a prescription, check that they do not contain calcium. Pregnancy and breast-feeding Before taking Phosex tablets, tell your doctor if you are pregnant, may become pregnant or are breast feeding. Driving and using machines Do not drive if you experience any of these uncommon side effects: feeling confused or delirious or that you may become unconscious. If in any doubt, consult your doctor or pharmacist.
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How to take it
PHOSEX TABLETS
Dosage • Take the tablets exactly as directed by your doctor. This is particularly important if you are elderly (aged 65 or over). •
The usual dose of Phosex is one to two tablets with each meal.
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You will start with one tablet with each meal and your doctor will adjust your dose as necessary over a few weeks.
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The maximum recommended daily dose is 12 tablets, but exactly how many tablets, and how often you must take them, will be written on the label. Please read the label carefully.
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Swallow the tablets whole with a little water. If you cannot swallow the tablets whole, they may be broken first. Do not chew them.
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Taking Phosex Tablets with antibiotics: If you have been prescribed antibiotics, Phosex should be taken with a meal at least three hours before or three hours after the antibiotic. You should discuss the timing of taking these two medicines with your doctor or pharmacist.
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If you forget to take Phosex If you forget to take a dose, do not worry; just take the next dose with the next meal. Never take two doses at the same time. If you take more Phosex than you should If you swallow too many tablets at one time, or if you think someone else, especially a child, has swallowed any of the tablets, go immediately to your nearest hospital emergency department or doctor, taking this leaflet or the tablets with you. If you stop taking Phosex You must finish all the tablets which your doctor has prescribed. Even if you feel better, you should still take all the tablets you have been given. It could be dangerous to stop taking the medicine without your doctor's advice.
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Possible side effects
Like all medicines, this medicine can cause side effects (especially when first taken), although not everybody gets them. Stop taking Phosex immediately and talk to your doctor or pharmacist if you experience allergic reactions such as rash, swelling, welts on the skin or breathing difficulties. Your doctor will monitor your blood calcium levels as hypercalcaemia (high blood calcium levels) can occur in some patients. Contact your doctor immediately, or go immediately to your nearest hospital emergency department, if you suffer any of the following uncommon side effects (occurring in less than 1 in every 1000 patients): • feeling confused • feeling delirious, • feeling you may soon become unconscious (stupor) • pain in your bones, • muscle weakness, • extreme thirst, • producing abnormally large quantities of urine. Common side effects (occurring in less than 1 in every 100 patients): • feeling sick • being sick • diarrhoea • constipation • loss of appetite. Please remember: The expected benefits of your medicine will usually be greater than the risk of suffering harmful side effects.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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How to store it
PHOSEX TABLETS Storage Keep this medicine out of the sight and reach of children. Do not store above 25°C. Store the tablets in their original bottle and keep the bottle tightly closed, to protect them from moisture. Do not use this medicine after the expiry date which is stated on the pack (EXP). The expiry date refers to the last day of that month. Disposal 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.
Contents of the pack and other information
What Phosex Tablets contain The active substance is calcium acetate 1000 mg, equivalent to 250 mg elemental calcium. The other ingredients are: macrogol 8000 sodium starch glycolate (type A) calcium stearate lemon meringue flavour containing lemon oil, citral, aldehyde C-9, lime oil, orange oil, vanillin, ethyl vanillin, malto-dextrin and tricalcium phopshate yellow iron oxide (E172). What Phosex Tablets look like and contents of the pack The tablets are pale yellow and embossed PHOS-EX on one side with a score-line on the reverse. They are available in bottles of 180 tablets Manufacturer and Batch Release Site Surepharm Services Ltd. Bretby Business Park Ashby Road, Bretby Burton on Trent, Staffordshire DE15 0YZ United Kingdom Marketing Authorisation Holder Pharmacosmos A/S Roervangsvej 30 DK-4300 Holbaek Denmark Tel.: +45 59 48 59 59 Fax: +45 59 48 59 60 E-mail: [email protected] This medicinal product is authorised in the Member States of the EEA under the following names: Ireland United Kingdom
Phosex Phosex
This leaflet was last revised in 10/2018 5
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Official document: view the original leaflet →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Correction of hyperphosphataemia associated with chronic renal failure in patients undergoing dialysis.
4.2. Posology and method of administration
For oral useInitially one tablet 3 times a day. The tablet should be swallowed whole with a meal to achieve the maximal phosphate binding effect. Where the patient cannot swallow the tablets whole they may be broken and taken with food. Tablets, whether whole or broken, should not be chewed due to their bitter taste. The dose can be increased until the desired serum phosphate level is achieved, as long as hypercalcaemia does not occur. Most patients need 4 to 6 tablets per day (1 to 2 tablets with each meal).The maximum recommended daily dose is 12 tablets.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients. Hypercalcaemia.
4.4. Special warnings and precautions for use
The use of phosphate binders in renal failure should be in conjunction with dietary advice regarding phosphate intake and methods of dialysis appropriate to the patient.The dose will need to be adjusted depending on phosphate intake or removal by dialysis and on the ensuing effect on serum calcium. This requires regular monitoring, for example weekly, of both the serum phosphate and calcium levels to determine efficacy and prevent hypercalcaemia.If hypercalcaemia occurs, the dosage should be reduced or the treatment withdrawn temporarily, depending on the degree of hypercalcaemia. The risk of hypercalcaemia needs to be considered particularly during concomitant treatment with Vitamin D preparations.The concomitant administration of calcium and vitamin D derivatives is to be made under the supervision of a physician. Patients suffering with progressive renal failure may exhibit signs of, and should be warned of the symptoms of, hypercalcaemia, ectopic or vascular calcification, or adynamic bone disease. Regular monitoring is required since caution is needed in administering Phosex under these circumstances. The long-term toxicity of Phosex has not been evaluated in clinical trials. In particular during long-term phosphate binding therapy with calcium salts there have been reports of tissue calcifications. It is not known whether the risk of calcification is higher with Phosex than with other calcium salts.Patients should be advised to seek medical advice before taking non-prescription antacids containing calcium carbonate or other calcium salts to avoid adding to the calcium load.
4.5. Interaction with other medicinal products and other forms of interaction
Calcium interacts with several drugs: - The absorption of antibiotics such as ciprofloxacin, enoxacin, norfloxacin, tetracyclines (PO) can be affected and consequently, the intake of Phosex should be made 3 hours before or after the antimicrobial treatment. - Vitamin D preparations may require dosage modification to avoid hypercalcaemia. - Digitalis glycosides, verapamil and gallopamil in the presence of hypercalcaemia can enhance cardiac effects and can lead to cardiac toxicity. Therefore, special precautions for use (ECG and biological surveillance) are to be taken.
4.6. Pregnancy and lactation
No data available. It is not known whether Phosex can cause foetal effects when administered during pregnancy or whether it can affect reproductive capacity.Phosex should only be administered to pregnant or lactating women if it is clearly indicated.
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
4.8. Undesirable effects
Uncommon (0.1% - 1%) Undesirable effects are nausea, vomiting, diarrhoea and constipation.Hypercalcaemia can occur and the serum levels of total and ionised calcium should be monitored. Mild hypercalcaemia (Ca >2.6 mmol/L) may occur in about 1% of patients and may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcaemia (Ca >3.0 mmol/L) may occur in about 0.1% of patients and can be associated with confusion, delirium, stupor and in very severe cases coma. Patients should be advised to consult their doctor if any of these symptoms occur.
4.9. Overdose
Overdose with calcium substances may lead to soft tissue calcifications.
💬 Ask about this leaflet
Ask anything about Phosex 1000mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.