Calciferol Side Effects

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Explain possible side effects and interaction/safety considerations for calciferol without overstating causality or efficacy.

What is calciferol?

Calciferol contains the active ingredient Alendronic acid and colecalciferol.

• Active ingredient — Alendronic acid and colecalciferol
• Registration number — 53/3.2/0225
• Registration holder — PHARMACARE LIMITED

It is approved for:

• PREOVIDLEN contains the active substances alendronic acid (alendronate) and cholecalciferol (vitamin D3)
• PREOVIDLEN belongs to a group of medicines called non-hormonal bisphosphonates
• PREOVIDLEN is used in women to treat post-menopausal osteoporosis (a disease that weakens the bones) and to help make sure they get enough vitamin D
• This will reduce the risk of developing fractures

Possible side effects of calciferol

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• if you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care
• if you have cancer. This may increase your risk of developing damage in the jaw (osteonecrosis) generally associated with delayed healing and infection
• if you are undergoing chemotherapy or radiotherapy, taking angiogenesis inhibitors (such as bevacizumab, or thalidomide) which are used in the treatment of cancer and taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of such conditions as asthma, rheumatoid arthritis, and severe allergies. This may also increase your risk of developing damage in the jaw (osteonecrosis) generally associated with delayed healing and infection
• if you are or have been a smoker (as this may increase the risk of dental problems)
• if you experience pain or discharge from the ear, or chronic ear infection as PREOVIDLEN can cause osteonecrosis (a bone disease) of the external auditory canal (i.e. from the opening of the ear to the eardrum)
• if you have bone, joint and/or muscle pain
• if you experience thigh, hip or groin pain as this can be an indication of a fracture of the thigh bone
• if you have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
• if you may have been advised to have a dental check-up before starting treatment with PREOVIDLEN
• if you have low calcium levels and produce low levels of parathyroid hormone (a hormone needed to keep your calcium and phosphorus levels balanced)
• if you have cancer of the blood (leukaemia), lymph nodes (lymphoma) or a condition that causes lumps or nodules to form in your organs (sarcoidosis). PREOVIDLEN may increase the magnitude of high calcium levels in your blood (hypercalcaemia) and excess calcium in your urine (hypercalciuria). It is important to maintain good oral hygiene when being treated with PREOVIDLEN. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling. Children There is no experience with PREOVIDLEN in children younger than 18 years. Other medicines and PREOVIDLEN Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:
• Calcium supplements, antacids, and some oral medicines as they will interfere with the absorption of PREOVIDLEN if taken at the same time. Therefore, it is important that you wait at least 30 minutes before taking any other oral medicines or supplements
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for the treatment of pain, swelling and inflammation due to injuries or short-term treatment of acute gout (e.g. acetylsalicylic acid or ibuprofen), might cause irritation to the stomach and intestine lining. Therefore, caution should be used when these medicines are taken at the same time as PREOVIDLEN
• Medicines for fits (seizures) (e.g. phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis
• Olestra, used in the preparation of otherwise high-fat food, thereby lowering or eliminating their fat content. Olestra may impair the absorption of vitamin D contained in PREOVIDLEN
• Mineral oils, used for the treatment of constipation, may impair the absorption of vitamin D contained in PREOVIDLEN
• Orlistat, used to aid in weight loss, may impair the absorption of vitamin D contained in PREOVIDLEN
• Bile acid sequestrates (e.g. colestyramine, cholesterol) used for to reduce low density lipoprotein (LDL) cholesterol levels, may impair the absorption of vitamin D contained in PREOVIDLEN
• Cimetidine, used for the treatment of heartburn, may increase the breakdown of vitamin D contained in PREOVIDLEN
• Thiazides e.g. hydrochlorothiazide, used to treat high blood pressure, may increase the breakdown of vitamin D contained in PREOVIDLEN. PREOVIDLEN with food and drink If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids and some oral medicines will likely reduce the absorption of PREOVIDLEN. PREOVIDLEN must be taken at least 30 minutes before the first food, beverage, or medication of the day with plain water only. Pregnancy and breastfeeding You should not take PREOVIDLEN if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking PREOVIDLEN. Driving and using machines Since adverse reactions such as dizziness and headache have been reported in patients receiving PREOVIDLEN, you should not drive, use machinery or perform any tasks that require concentration, until you are certain that PREOVIDLEN does not adversely affect your ability to do so. It is not always possible to predict to what extent PREOVIDLEN may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which PREOVIDLEN affects you. PREOVIDLEN contains lactose and sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking PREOVIDLEN. TEOVILEN FORTE contains less the 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”

Interactions and medicines to check

Interactions happen when calciferol and something else affect each other — changing how well either works, or making side effects more likely. This includes prescription medicines, pharmacy medicines bought without a prescription, other supplements, herbal remedies and traditional medicines.

Supplements and herbal products are often assumed to be interaction-free because they are available without a prescription. That assumption is not safe. Tell your pharmacist or doctor about everything you take, including things you would not think of as medicine.

Who should use extra caution?

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to alendronic acid, cholecalciferol or any of the other ingredients of PREOVIDLEN (listed in section 6)
• if you have certain problems with your oesophagus (the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least 30 minutes
• if your doctor has told you that you have low blood calcium
• if you have kidney problems
• if you are pregnant or breastfeeding
• if the patient is a child

Use with care, and tell your doctor, if

• if you have, or have recently had, any swallowing or digestive problems including disease of the oesophagus (the tube that connects your mouth with your stomach), inflammation of the lining of the stomach (gastritis) and part of your small intestine (duodenitis), a sore in the lining of your stomach (ulcer) and active bleeding from your stomach
• if you recently had surgery in your upper stomach area (gastrointestinal tract)
• if your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
• if you have irritation, inflammation or ulceration of the oesophagus (the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if you do not drink a full glass of water and/or if you lie down less than 30 minutes after taking PREOVIDLEN. These

Dose, timing and other factors that can affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to alendronic acid, cholecalciferol or any of the other ingredients of PREOVIDLEN (listed in section 6)
• if you have certain problems with your oesophagus (the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least 30 minutes
• if your doctor has told you that you have low blood calcium
• if you have kidney problems
• if you are pregnant or breastfeeding
• if the patient is a child

Use with care, and tell your doctor, if

• if you have, or have recently had, any swallowing or digestive problems including disease of the oesophagus (the tube that connects your mouth with your stomach), inflammation of the lining of the stomach (gastritis) and part of your small intestine (duodenitis), a sore in the lining of your stomach (ulcer) and active bleeding from your stomach
• if you recently had surgery in your upper stomach area (gastrointestinal tract)
• if your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)
• if you have irritation, inflammation or ulceration of the oesophagus (the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if you do not drink a full glass of water and/or if you lie down less than 30 minutes after taking PREOVIDLEN. These

Serious symptoms and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

What to do if side effects occur

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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