Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of Modip in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems which may require an adjustment of dose in patients receiving Modip.
Urgent advice: Call your doctor or go to A&E straight away if you take too much Modip
If you need to go to a hospital accident and emergency (A&E) department, do not drive yourself - get someone else to drive you or call for an ambulance.
Take the Modip box, or the leaflet inside the packet, plus any remaining medicine with you.
Like all medicines, Modip can cause side effects, although not everyone gets them. Side effects often improve as your body gets used to the medicine.
Clinical studies of Modip did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Pharmacokinetics, however, indicate that the availability of Modip is increased in older patients (see CLINICAL PHARMACOLOGY, Geriatric Use). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
** Based on patient weight of 50 kg
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year carcinogenicity study in rats fed Modip at doses of 7.7, 23.1 or 69.3 mg/kg/day (up to 61 times** the maximum recommended human dose on a mg/m 2 basis), a dose-related increase in the inc >2 basis). Modip, at the doses employed in the 2-year rat study, has been shown to lower testicular testosterone and to produce a corresponding increase in serum luteinizing hormone in rats. The Leydig cell tumor development is possibly secondary to these hormonal effects which have not been observed in man.
In this same rat study a dose-related increase in the incidence of focal squamous cell hyperplasia compared to control was observed in the esophageal groove of male and female rats in all dose groups. No other drug-related esophageal or gastric pathology was observed in the rats or with chronic administration in mice and dogs. The latter species, like man, has no anatomical structure comparable to the esophageal groove.
Modip was not carcinogenic when fed to mice at doses up to 138.6 mg/kg/day (61 times** the maximum recommended human dose on a mg/m 2 basis) for periods of up to 80 weeks in males and 99 weeks in females.
** Based on patient weight of 50 kg
Modip d >in vitro in the Ames microbial mutagenicity test or in the mouse lymphoma forward mutation assay. No clastogenic potential was seen in vivo in the mouse micronucleus test at oral doses up to 2500 mg/kg (1100 times** the maximum recommended human dose on a mg/m 2 basis) or in vitro in a human lymphocyte chromosome aberration assay.
A fertility study in which male and female rats were administered doses of 3.8, 9.6 or 26.9 mg/kg/day (up to 24 times** the maximum recommended human dose on a mg/m 2 basis) showed no significant effect of Modip on reproductive performance.
Other medical problems
The presence of other medical problems may affect the use of Modip. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart failure—Use with caution. May make this condition worse.
Immediate action required: Call 999 or go to A&E if:
- you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
- you're wheezing
- you get tightness in the chest or throat
- you have trouble breathing or talking
- your mouth, face, lips, tongue or throat start swelling
You could be having a serious allergic reaction and may need immediate treatment in hospital.
These are not all the side effects of Modip. For a full list see the leaflet inside your medicines packet.
You can report any suspected side effect to the UK safety scheme.
2. Key facts
- Modip lowers your blood pressure and makes it easier for your heart to pump blood around your body.
- It's usual to take Modip once a day in the morning.
- Do not eat grapefruit or drink grapefruit juice while you're taking Modip. Grapefruit can make side effects worse.
- Modip is also called by various brand names, including Plendil, Cardioplen XL, Folpik XL, Vascalpha and Neofel XL.
Before taking Modip
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Modip it is important that your doctor knows:
- If you have any heart problems (other than angina or high blood pressure).
- If you are pregnant or breast-feeding.
- If you have problems with the way your liver works.
- If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
- If you have ever had an allergic reaction to a medicine.
Michael Stewart, Reviewed by Sid Dajani | Last edited 9 Jun 2017 | Certified by The Information Standard
Modip is taken once a day.
You can take the tablet before or after meals.
When you first start taking Modip you may get a headache or feel flushed. These symptoms usually go after a few days.
Do not drink grapefruit juice while you are taking Modip.
What is Modip (Plendil)?
Modip may also be used for purposes not listed in this medication guide.